Roche: hemophilia drug wins another FDA approval

(CercleFinance.com) - The FDA has approved Roche's Hemlibra for routine prophylaxis of haemophilia A without factor VIII inhibitors, the Swiss drugmaker said on Friday.


Hemlibra may be self-administered subcutaneously once weekly - either every two weeks or every four weeks - while many preventative treatment options for people with haemophilia A without factor VIII inhibitors require intravenous infusions several times a week, the group said.

This approval is based on positive results from phase III studies which showed that Hemlibra led to statistically significant and clinically meaningful reductions in bleeds compared to no prophylaxis and showed a clinically meaningful control of bleeding.

Hemlibra was approved by the FDA in November 2017 for adults and children with haemophilia A with factor VIII inhibitors.

Copyright (c) 2018 CercleFinance.com. All rights reserved.