(Reuters) - Biogen Idec Inc on Monday said the U.S. Food and Drug Administration will extend by three months its deadline for reviewing the company’s experimental long-acting medicine for hemophilia.
Biogen, which is developing the drug in partnership with Swedish Orphan Biovitrum AB, said it had provided the FDA additional information related to validation of a manufacturing step for the medicine, called Alprolix.
It is the first member of a new class of drugs for Hemophilia B, a rare inherited disorder in which the ability of a person’s blood to clot is impaired.
Biogen last summer said the drug, in a late-stage trial, had consistently controlled bleeding during and after 14 major surgeries in 12 patients with the condition.
The company has described the drug as the first major treatment advance for hemophilia B in 15 years.
Biogen in January said it had asked the FDA to approve Alprolix.
Reporting by Ransdell Pierson; Editing by Gerald E. McCormick