Roche’s Hemlibra Receives Expanded FDA Approval

The FDA has granted another approval for Roche’s Hemlibra, this time for preventing or reducing the frequency of bleeding episodes in patients of newborn age or older caused by hemophilia A without factor VIII inhibitors.

The agency’s green light makes Roche’s drug the only approved treatment for hemophilia A patients without factor VIII inhibitors that can be administered under the skin in multiple dosing options –weekly, biweekly or monthly. In the drugmaker’s Haven 4 phase III study, over half of patients with or without the disease treated with Hemlibra monthly experienced zero bleeds and 90.2 percent experienced three or fewer bleeds.

The agency previously OK’d the treatment in November 2017 to treat adults and children with hemophilia A with factor VIII inhibitors.