U.S. FDA Expands Indication for Roche's Bleeding Disorder Drug

By Reuters Staff

October 05, 2018

(Reuters) - Roche said on Thursday it received approval from U.S. regulators for its hemophilia A drug Hemlibra (emicizumab) for use in nearly all patients, as the Swiss drugmaker pushes deeper into diseases beyond cancer to replace revenue from older, patent-expired drugs.

Hemlibra was first approved in November for adults and children with hemophilia A with factor VIII inhibitors.

The FDA has now approved Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A without factor VIII inhibitors.

Hemlibra is now the only prophylactic treatment for people with haemophilia A with and without factor VIII inhibitors that can be administered subcutaneously and at multiple dosing options (once weekly, every two weeks or every four weeks), the company said in a news release.