FDA grants accelerated review to Roche's Hemlibra

Apr 17, 2018

Roche’s hemophilia A drug Hemlibra will receive accelerated review by the U.S. Food and Drug administration for use in a new group of patients.

The FDA has given breakthrough therapy designation to the medicine to be used in people who have not yet developed resistance to conventional treatments. Hemlibra is approved for people with inhibitors.

According to Roche, the breakthrough designation is based on a phase III HAVEN 3 study demonstrating Hemlibra prophylaxis significantly reduced bleeds compared to no prophylaxis. The drugmaker also says that it is the first medicine to show superior efficacy compared to prior factor VIII prophylaxis in an intra-patient comparison.

Read the Roche release