Tuesday, January 13, 2009

FDA Panel Backs CSL Ltd Anti-Bleeding Drug Riastap

A Food and Drug Administration panel of outside medical experts Friday backed an anti-bleeding product from a subsidiary of Australia's CSL Ltd. (CSL.AU) to treat a rare blood disorder. The product, which would be sold in the U.S. under the brand name Riastap by CSL Behring, is designed to treat congenital fibrinogen deficiency, a rare bleeding disorder resulting from deficiency of fibrinogen. It's made from human plasma and would boost levels of fibrinogen. The panel unanimously said the product was safe and that it appeared to be effective at treating the blood condition. The panel's decision amounts to a recommendation that the FDA approve the product. The FDA usually follows its panels' advice but isn't required to. The agency has set a Jan. 16 deadline to act on Riastap, although it isn't clear if that deadline will be met given the proximity of the panel meeting. The company estimates only about 300 people in the U.S. have congenital fibrinogen deficiency. Fibrinogen, also known as Factor I, is a protein needed to form a blood clot. Earlier this week, the FDA released a review of Riastap, which said the product appeared to be safe and effective. The agency said clinical studies showed Riastap was effective at increasing clot firmness, but said it will require CSL to continue studying patients to see if it results in a reduction of actual bleeding events. Riastap is being considered under the FDA's accelerated review mechanism, which allows products to be approved on less data than typically required. Companies with products granted accelerated approval are required to continue studying the products and eventually submit the data to gain full or regular approval. Riastap is currently sold in 12 countries under the name Haemocomplettan P, according to the FDA.

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