Biotech drugmaker Amgen Inc. is expected to receive a decision this week from federal regulators on its experimental drug to treat a blood-clotting disorder.
The Thousand Oaks, Calif.-based company has asked the Food and Drug Administration to approve Nplate for patients with a disorder that causes the body to attack its own platelets, tiny components of blood that help with clotting.
The condition, which causes bruising and bleeding after minor injuries, affects about 200,000 people in the U.S., according to the Platelet Disorder Association. Nplate mimics a naturally occurring human protein that spurs platelet production.
The drug is likely to receive clearance from the FDA, considering an outside panel of agency advisers unanimously recommended its approval at a meeting earlier this year. The FDA generally follows the groups' recommendations, though it is not required to do so.
The agency is expected to make a decision on the drug by Wednesday.
Robert W. Baird & Co. analyst Christopher Raymond wrote in a note earlier this month that Nplate is one of several new Amgen therapies, including treatments for bone disease and cancer, which should provide a boost to its stock price.
"We look for these later-stage pipeline candidates to provide for meaningful catalysts for the stock in the near term," Raymond stated.
If Nplate is approved it could soon face competition from a similar drug developed by British firm GlaxoSmithKline and partner Ligand Pharmaceuticals. They are seeking FDA clearance for their drug Promacta, which also received unanimous support for the agency's outside advisers. But while Nplate is an injectable drug designed for long-term use, Promacta is a daily pill designed for short-term use.
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