SAN FRANCISCO, Jun 21, 2008 (Thomson Financial via COMTEX) - GlaxoSmithKline late Friday said the Food and Drug Administration has extended to Sept. 19 the priority review period for Promacta, a short-term treatment for idiopathic thrombocytopenic purpura.
ITP is a condition in which the blood doesn't clot properly because patients don't have sufficient platelets.
The FDA's oncology drugs advisory committee May 30 unanimously voted that Promacta demonstrated a favorable risk-benefit profile for the short-term treatment of patients with chronic ITP, GlaxoSmithKline said.
U.S.-listed shares of the UK-based pharmaceutical company down 27 cents at $43.37. Brigid Gaffikin bg/gm
