GlaxoSmithKline Plc (GSK) said it was granted accelerated FDA approval for a new oral medication to boost platelet production in people with a kind of serious blood disorder.
The drug called PROMACTA is approved as a treatment for chronic immune thrombocytopenic purpura or ITP, an autoimmune condition in which the body's immune system destroys its own blood platelets that play a role in blood clotting.
The disease results in low blood platelet counts and people with a low blood platelet count bleed more easily than others and bruise more often. The drug is approved to treat chronic ITP patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Corticosteroids are a class of steroid hormones, while Immunoglobulins are anti bodies in the blood, and Splenectomy is the surgical removal of the spleen.
The approval was expected as an FDA panel endorsed the drug in May, after finding that benefits of the drug outweighed risks for the short-term treatment of chronic ITP, which affects an estimated 60,000 individuals in the U.S.
Specialty drugs that treat rare conditions in a small population typically tend to fetch lofty prices, as patients are left with very little alternatives. Competition is less or literally non-existent, as the drug may be protected by patents or may be difficult to make.
GSK expects to make the drug available by next week and plans to file a marketing application for the drug in Europe this year.
After a few attempts to break through a resistance level around $53 in late 2007 and early 2008, the stock has retreated with the broader markets and is currently trading around $32. In Friday's pre-market hours, the stock was up 91 cents just before 8:20 am ET, and at $33.45.
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