FDA decision on emicizumab in hemophilia A due within five months

Swiss pharma giant Roche’s (ROG: SIX) regulatory application for emicizumab in hemophilia A has been given priority review status by the US Food and Drug Administration.

Roche has applied to market the monoclonal antibody as a once-weekly subcutaneous treatment for adult, adolescent and child patients who have developed inhibitors to factor VIII.

The development of such inhibitors, which occurs in up to a third of cases, limits treatment options and increases the severity and impact of the disease.