Baxter International has filed an application to the US Food and Drug Administration (FDA) for a pediatric indication for Rixubis [Coagulation Factor IX (Recombinant)] to treat hemophilia B.
The submission was based on a Phase II/III clinical trial, designed to assess the efficacy and safety of Rixubis in 23 previously-treated male patients less than 12 years of age with severe or moderately severe hemophilia B.
In 2013, the company had secured FDA approval for Rixubis in the US for adults with hemophilia B and it had filed for marketing approval in Europe in November.
During the trial, patients were treated with a twice-weekly Rixubis prophylaxis regimen (median dose 56 IU/kg) over six months or for a minimum of 50 exposure days (EDs).
The company said that the median annualized bleeding rate (ABR) was 2.0 (0.0 for spontaneous bleeds and joint bleeds).
In the trial nine patients (39.1%) experienced no bleeds and 23 patients (88.5%) were treated with 1-2 infusions.
The company said that out of the 26 bleeds seen in the trial, only two (in two patients) were spontaneous and no reports of inhibitor development, no allergic reactions, and no thrombotic or treatment-related adverse events were observed among the study participants.
Baxter BioScience vice president of global research and development Anders Ullman said the positive results among a pediatric patient population are consistent with those observed in the Rixubis pivotal study among adult patients with hemophilia B.
"We submitted these data as part of our application for a pediatric indication for RIXUBIS to advance effective therapeutic solutions for children with hemophilia B," Ullman said.
Wednesday, December 11, 2013
New dissolving patch delivers clotting factor directly to injury to stop bleeding faster
Hemorrhage is a primary cause of mortality in trauma patients even though most injuries suffered are potentially survivable. Increasing survival is simply a matter of effectively controlling hemorrhage. Current hemostatic dressings range from simple gauze to aluminosilicates from natural or synthetic clay Combat GauzeTM, or chitosan from shellfish or algae (CeloxTM). These dressings stop the bleeding by direct compression of injured vessels and/or activation of the intrinsic coagulation pathway. In trauma patients however, this system is often compromised.
Current dressings are also unstable, which increases the chance of rebleeding due to movement. The next generation of advanced dressings will likely incorporate plasma-coagulation factors such as fibrinogen that would directly form fibrin clots and seal injured vessels. Hemostasis would be independent of a person’s injuries, and re-bleeding would be less likely also.
St. Teresa Medical, Inc., a medical device company in Minnesota, is commercializing this kind of hemostatic technology platform called FASTCLOT®. The patent-pending FASTCLOT products use an electrospun nano-fiber dextran matrix carrier along with fibrin producing proteins such as thrombin and fibrinogen. The carrier in all FASTCLOT products dissolves in seconds to minutes when in contact with fluid, effectively releasing the clot forming proteins at the bleeding site. As a result, the clotting cascade is accelerated, generating a quick and robust clot in both arterial and venous bleeding, preventing excess blood loss. Most importantly, the FASTCLOT platform technology is the only completely dissolvable and absorbable fibrin sealant that will be available in the market. As opposed to other fibrin sealants, FASTCLOT products leave nothing behind in the patient’s body, eliminating the risk for scarring, inflammation and re operative surgery.
The FASTCLOT technology was developed by a research team at Virginia Commonwealth University and is exclusively licensed by St Teresa Medical. The company is developing products for both surgery (SURGICLOT®) and trauma (WRAPCLOT®), for civilian and military markets. St. Teresa Medical also owns a subsidiary, St. Francis Veterinary Medical, where the product ANIMALCLOT® designed for animal use and developed using the same FASTCLOT technology is currently being sold.
Fibrin dressings have great life-saving potential but their use is limited by availability, cost and safety. CEO and co-founder Phil Messina said St Teresa Medical products can overcome these limitations. St Teresa has completed several pre-clinical animal studies demonstrating the safety and efficacy of the technology. All studies indicated no allergic, immunogenic or thrombolytic events. The FASTCLOT products are reliable, robust and inexpensive hemostatic agents, Messina said.
“We create value for the patient, surgeon, hospital and payer delivering better clinical outcomes,” he said.
St. Teresa Medical products have an estimated global market potential of several billion dollars. Surgical applications represent the single largest market. The company has raised up to $4 million since its inception. St Teresa Medical expects a CE Mark approval on its SURGICLOT fibrin sealant in mid 2014 in Europe and subsequent approval in the US through a Biologics License Application (BLA) submission approximately 18 months later.
Current dressings are also unstable, which increases the chance of rebleeding due to movement. The next generation of advanced dressings will likely incorporate plasma-coagulation factors such as fibrinogen that would directly form fibrin clots and seal injured vessels. Hemostasis would be independent of a person’s injuries, and re-bleeding would be less likely also.
St. Teresa Medical, Inc., a medical device company in Minnesota, is commercializing this kind of hemostatic technology platform called FASTCLOT®. The patent-pending FASTCLOT products use an electrospun nano-fiber dextran matrix carrier along with fibrin producing proteins such as thrombin and fibrinogen. The carrier in all FASTCLOT products dissolves in seconds to minutes when in contact with fluid, effectively releasing the clot forming proteins at the bleeding site. As a result, the clotting cascade is accelerated, generating a quick and robust clot in both arterial and venous bleeding, preventing excess blood loss. Most importantly, the FASTCLOT platform technology is the only completely dissolvable and absorbable fibrin sealant that will be available in the market. As opposed to other fibrin sealants, FASTCLOT products leave nothing behind in the patient’s body, eliminating the risk for scarring, inflammation and re operative surgery.
The FASTCLOT technology was developed by a research team at Virginia Commonwealth University and is exclusively licensed by St Teresa Medical. The company is developing products for both surgery (SURGICLOT®) and trauma (WRAPCLOT®), for civilian and military markets. St. Teresa Medical also owns a subsidiary, St. Francis Veterinary Medical, where the product ANIMALCLOT® designed for animal use and developed using the same FASTCLOT technology is currently being sold.
Fibrin dressings have great life-saving potential but their use is limited by availability, cost and safety. CEO and co-founder Phil Messina said St Teresa Medical products can overcome these limitations. St Teresa has completed several pre-clinical animal studies demonstrating the safety and efficacy of the technology. All studies indicated no allergic, immunogenic or thrombolytic events. The FASTCLOT products are reliable, robust and inexpensive hemostatic agents, Messina said.
“We create value for the patient, surgeon, hospital and payer delivering better clinical outcomes,” he said.
St. Teresa Medical products have an estimated global market potential of several billion dollars. Surgical applications represent the single largest market. The company has raised up to $4 million since its inception. St Teresa Medical expects a CE Mark approval on its SURGICLOT fibrin sealant in mid 2014 in Europe and subsequent approval in the US through a Biologics License Application (BLA) submission approximately 18 months later.
Cohera Medical, Inc.® Successfully Completes Clinical Trial and Confirms Safety of Sylys® Surgical Sealant
PITTSBURGH, Dec. 10, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has successfully completed a clinical trial confirming the safety of Sylys®Surgical Sealant designed to significantly reduce anastomotic leakage in intestinal procedures. The European study included patients enrolled at two sites in the Netherlands.
Sylys is one of the first synthetic sealants specifically designed to significantly reduce anastomotic leakage in intestinal anastomosis procedures. Used in conjunction with standard anastomotic closure techniques, Sylys protects the suture or staple line, supporting the anastomosis during the first few days of healing, when leaks are most likely to occur.
"Sylys enhances standard closure techniques, advancing the healing process and reducing post-operative complications," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "With the completion of this study, we are a step closer to providing patients with the best opportunity for a successful outcome following intestinal anastomosis procedures."
On average, anastomotic leaks occur in 3-15% of colorectal procedures, and are the cause of one-third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1-4B market.
Thursday, November 21, 2013
European Medicines Agency Accepts Marketing Authorization Application for The Medicines Company's Fibrocaps
PARSIPPANY, NJ--(Nov 21, 2013) - The Medicines Company (MDCO) today announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational hemostatic agent Fibrocaps (human plasma-derived fibrinogen and thrombin). Fibrocaps was studied in the 719-patient Phase III FINISH-3 clinical trial as an adjunct to hemostasis in patients undergoing surgical procedures when control of mild or moderate bleeding by conventional surgical techniques is ineffective or impractical.
The acceptance of the MAA marks the beginning of the review process in the European Union for Fibrocaps. The Company anticipates submitting a biologics license application (BLA) with the United States Food and Drug Administration in the first quarter of 2014. The Company also plans to submit a 510(k) application with the FDA for the complementary spray delivery device to assist surgeons in the accurate application of the dry powder Fibrocaps. The device was recently granted a European CE mark.
"We believe Fibrocaps can become an important hemostatic solution within our surgery and perioperative care portfolio upon regulatory approval," said Jan Ohrstrom, MD, Senior Vice President Global Launch Leader, Hemostasis Solutions of The Medicines Company. "We are expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare."
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Forward-looking Statements
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "plans, "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Registration Statement on Form 10-Q filed on November 5, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The acceptance of the MAA marks the beginning of the review process in the European Union for Fibrocaps. The Company anticipates submitting a biologics license application (BLA) with the United States Food and Drug Administration in the first quarter of 2014. The Company also plans to submit a 510(k) application with the FDA for the complementary spray delivery device to assist surgeons in the accurate application of the dry powder Fibrocaps. The device was recently granted a European CE mark.
"We believe Fibrocaps can become an important hemostatic solution within our surgery and perioperative care portfolio upon regulatory approval," said Jan Ohrstrom, MD, Senior Vice President Global Launch Leader, Hemostasis Solutions of The Medicines Company. "We are expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare."
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Forward-looking Statements
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "plans, "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Registration Statement on Form 10-Q filed on November 5, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Study: Closure devices cut complications after cardiac procedure (VIDEO)
The use of vascular closure devices significantly reduced complications and the need for transfusions in obese and overweight patients undergoing transfemoral percutaneous coronary intervention (PCI), but the benefit over manual closure was not seen in lean and normal-weight patients or in those treated with a glycoprotein IIb/IIIa inhibitor, researchers reported.
The benefit was also counterbalanced by a small increase in risk of retroperitoneal bleeding, Hitinder S. Gurm, MD, of the University of Michigan Cardiovascular Center in Ann Arbor, and colleagues, wrote online in the Annals of Internal Medicine.
Vascular closure devices (VCDs) are designed to prevent arterial bleeding, especially after PCI performed by the transfemoral route, which is still the most common route in the U.S.
The devices permit closure of the arteriotomy site using sutures, plugs, or metallic clips, but the role of these devices in preventing vascular complications remains controversial, the researchers noted.
"Most randomized trials evaluating VCDs have been small and underpowered, and the largest meta-analysis on the subject raised concerns that these devices may be associated with an increase in vascular complications," they wrote. "These devices are commonly used in clinical practice, and a recent large observational study suggested that they may be associated with a reduction in bleeding complications."
The newly published study is among the first to compare the efficacy of VCDs to manual closure in the real-world PCI practice setting, with the focus on specific subgroups with the highest risk for complications.
Researchers collected data on 92,000 patients who had PCI procedures at 32 Michigan hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) between 2007 and 2009.
Of the 85,048 PCIs that met study inclusion criteria, 28,528 (37%) used VCDs.
A main study endpoint was vascular complications, including acute thrombosis, loss of limb, retroperitoneal bleeding, need for surgical repair, pseudoaneurysm, or hematoma requiring transfusion or arteriovenous fistula. Other endpoints included transfusion or in-hospital death.
Using propensity score-matched analysis, the use of VCDs was found to be associated with reductions in vascular complications (OR 0.78, 95% CI 0.67-0.90, P=0.001) and post-procedure transfusions (OR 0.85 CI 0.74-0.96, P=0.011).
"These findings were consistent across many prespecified subgroups except for patients with a BMI less than 25 kg/m2 and those treated with platelet glycoprotein IIb/IIIa inhibitors, in whom the benefit of VCDs over manual closure was attenuated," the researchers wrote.
When specific subtypes of vascular complications were evaluated, VCDs were associated with fewer hematomas (OR 0.69 CI 0.58-0.83, P<0 .001="" 0.38-0.76="" 0.54="" 1.12-2.20="" 1.57="" also="" an="" associated="" bleeding="" but="" ci="" in="" increase="" odds="" of="" or="" p="0.009).</span" pseudoaneurysms="" retroperitoneal="" the="" they="" were="" with="">
"Our sudy supports the conclusion that VCDs are associated with reduced vascular complications and transfusions," Gurm and colleagues wrote, adding that the benefit of these devices was evident only in obese and overweight patients in whom manual control of access site is usually difficult.
The study also confirmed that VCD use is particularly beneficial in patients treated with bivalirudin and that its use was associated with a significantly increased risk for retroperitoneal bleeding, which negated any benefit in patients who received GP IIb/IIIa.
"Our data suggest that physicians contemplating VCD use should carefully weigh this increased risk for retroperitoneal bleeding against the expected reduction in pseudoaneurysms and hematomas," the researchers wrote. "The decision to use these devices needs to be individualized for each patient."
Tuesday, November 19, 2013
Cohera Medical, Inc.® Completes Fourth and Final Module in the Premarket Approval (PMA) Application for TissuGlu® Surgical Adhesive
PITTSBURGH, Nov. 19, 2013 -- PITTSBURGH, Nov. 19, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today it has submitted its fourth and final module for TissuGlu® Surgical Adhesive in the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA).
"We are pleased to have submitted the final module of the PMA application for TissuGlu," said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. "This module culminates substantial work by the Cohera team and our investigational partners."
A modular PMA submission is one in which the contents of a PMA are broken into several clearly defined parts or modules. These modules are submitted separately over time and comprise a complete PMA when all of them have been submitted. FDA reviews each module separately which may allow for a more efficient review when the last components are submitted because much of the review work will have already been completed. Cohera Medical has already successfully submitted the first three modules of the PMA application: biocompatibility, design control and manufacturing.
The fourth and final module submitted is comprised of data from Cohera Medical's 'No Drain' study, confirming that TissuGlu is a clinically superior alternative to closed-suction drains for fluid management in large flap procedures such as abdominoplasty. In the pivotal clinical trial, when TissuGlu was used, patients required fewer post-operative treatments and resumed normal activities, such as going to work, showering and using the stairs, more quickly.
"Submitting the final module to FDA is a critical milestone in making TissuGlu Surgical Adhesive available to surgeons and patients in the U.S.," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "The successful completion of this module represents a huge effort on the part of the entire company and we look forward to continuing our work with FDA."
Currently, most patients who undergo abdominoplasty procedures or other large flap procedures, such as mastectomy or inguinal lymph node dissection, require the insertion of drains to remove fluid that accumulates under the skin at the surgical site. Drains are often uncomfortable for the patient and can lead to additional complications. TissuGlu forms a strong bond between tissue layers, helping to reduce the fluid that can accumulate during healing.
Clinical Papers Hemostats Reviewed - Oxi Cell, Gelatin, Collagen, Thrombin, Polysaccharide Powders
A lot of our earlier embedded document links have gone since our previous embedding agency sold (these things happen in 5 years of blogging). Now Google have this facility I am happy to provide you clinical data for your interest in the links below.
Friday, November 15, 2013
Baxter completes patient enrollment in phase III trial of BAX 855, extended half-life rFVIII to treat haemophilia A
Baxter International Inc. has completed enrollment in its phase III clinical trial of BAX 855, an investigational extended half-life, recombinant factor VIII (rFVIII) treatment for haemophilia A. The ongoing trial is aimed at assessing the efficacy of the compound in reducing annualized bleed rates (ABR) in both prophylaxis and on-demand treatment schedules, and will also evaluate its safety and pharmacokinetic profile.
BAX 855 was designed based on the full-length ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] molecule, a product with 10 years of real-world experience. The BAX 855 molecule was modified with PEGylation technology designed to extend its duration of activity in the body.
"The BAX 855 development programme is a priority for Baxter as we evaluate the potential to provide an efficacious and safe treatment with an extended half-life for patients with hemophilia," said Anders Ullman, MD, Ph.D., vice president of global research and development in Baxter's BioScience business. "We are focused first and foremost on strategies to address optimal efficacy and minimize patients' bleeding episodes, while at the same time delivering on the convenience of less frequent dosing for this population with severe disease."
The phase II/III multi-centre, open-label study called PROLONG-ATE is evaluating BAX 855 among 146 adult patients with previously-treated severe haemophilia A. Patients participating in PROLONG-ATE receive treatment twice weekly (45 IU/kg) and are followed for six months. The primary endpoint of the study is the annualized bleed rate (ABR) during the treatment period. The study is also evaluating the safety and immunogenicity of the compound when administered on either prophylaxis and on-demand treatment regimens. Other outcome measures include number of infusions needed to treat bleeding episodes, time intervals between these episodes, pharmacokinetics and patient reported outcomes. To date, no inhibitors or safety issues have been reported in the study.
Based upon the results of the study, the company expects to complete the trial and file for regulatory approval late in 2014. Baxter is also initiating a continuation study for all patients who complete the pivotal phase II/III study, and expects to initiate a study of BAX 855 among pediatric patients in 2014.
The treatment protocol is based on the results of a phase I trial of BAX 855, assessing its safety, tolerability and pharmacokinetics. That trial found that the half-life (measuring the duration of activity of the drug in the body) of the investigational compound was approximately 1.5-fold higher compared to ADVATE. An extended half-life was achieved in all patients in the study using BAX 855, no patients developed inhibitors to either the base molecule, BAX 855 or to PEG, and no patients had allergic reactions. No treatment-related or serious adverse events were reported, and no patients withdrew from the study due to adverse events.
BAX 855 is built from the same native FVIII protein used in the production of ADVATE, and employs proprietary PEGylation technology from Nektar Therapeutics designed to extend the duration of activity of proteins. PEGylation technology has been widely used in various approved treatments.
ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] is indicated for the control and prevention of bleeding episodes in adults and children (0-16 years) with haemophilia A. ADVATE is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with haemophilia A. ADVATE is not indicated for the treatment of von Willebrand disease.
ADVATE has a demonstrated efficacy profile and a low rate of inhibitor development. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.
ADVATE is approved in 60 countries worldwide including the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Ecuador, Hong Kong, Iceland, Iraq, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay, and Venezuela.
BAX 855 was designed based on the full-length ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] molecule, a product with 10 years of real-world experience. The BAX 855 molecule was modified with PEGylation technology designed to extend its duration of activity in the body.
"The BAX 855 development programme is a priority for Baxter as we evaluate the potential to provide an efficacious and safe treatment with an extended half-life for patients with hemophilia," said Anders Ullman, MD, Ph.D., vice president of global research and development in Baxter's BioScience business. "We are focused first and foremost on strategies to address optimal efficacy and minimize patients' bleeding episodes, while at the same time delivering on the convenience of less frequent dosing for this population with severe disease."
The phase II/III multi-centre, open-label study called PROLONG-ATE is evaluating BAX 855 among 146 adult patients with previously-treated severe haemophilia A. Patients participating in PROLONG-ATE receive treatment twice weekly (45 IU/kg) and are followed for six months. The primary endpoint of the study is the annualized bleed rate (ABR) during the treatment period. The study is also evaluating the safety and immunogenicity of the compound when administered on either prophylaxis and on-demand treatment regimens. Other outcome measures include number of infusions needed to treat bleeding episodes, time intervals between these episodes, pharmacokinetics and patient reported outcomes. To date, no inhibitors or safety issues have been reported in the study.
Based upon the results of the study, the company expects to complete the trial and file for regulatory approval late in 2014. Baxter is also initiating a continuation study for all patients who complete the pivotal phase II/III study, and expects to initiate a study of BAX 855 among pediatric patients in 2014.
The treatment protocol is based on the results of a phase I trial of BAX 855, assessing its safety, tolerability and pharmacokinetics. That trial found that the half-life (measuring the duration of activity of the drug in the body) of the investigational compound was approximately 1.5-fold higher compared to ADVATE. An extended half-life was achieved in all patients in the study using BAX 855, no patients developed inhibitors to either the base molecule, BAX 855 or to PEG, and no patients had allergic reactions. No treatment-related or serious adverse events were reported, and no patients withdrew from the study due to adverse events.
BAX 855 is built from the same native FVIII protein used in the production of ADVATE, and employs proprietary PEGylation technology from Nektar Therapeutics designed to extend the duration of activity of proteins. PEGylation technology has been widely used in various approved treatments.
ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] is indicated for the control and prevention of bleeding episodes in adults and children (0-16 years) with haemophilia A. ADVATE is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with haemophilia A. ADVATE is not indicated for the treatment of von Willebrand disease.
ADVATE has a demonstrated efficacy profile and a low rate of inhibitor development. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.
ADVATE is approved in 60 countries worldwide including the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Ecuador, Hong Kong, Iceland, Iraq, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay, and Venezuela.
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