FDA approves Roche hemophilia drug Hemlibra
ZURICH (Reuters) – The U.S. Food and Drug Administration on Thursday approved Roche’s Hemlibra for hemophilia suffers, a new medicine the Swiss drugmaker is counting on to help it offset eroding sales of its older medicines that have begun going off patent.
The U.S. regulator approved the drug, also known as ACE910 or emicizumab, as a once-weekly injection for adults and pediatric patients with hemophilia A with factor VIII inhibitors.
The medicine will carry a boxed warning that blood clots were seen in patients who were given rescue treatment to treat bleeds for 24 hours while taking Hemlibra.
Reporting by John Miller