Roche: wins FDA's breakthrough therapy for haemophilia drug
(CercleFinance.com) - Roche said on Tuesday that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to its Hemlibra antibody for people with haemophilia A without factor VIII inhibitors.
Last year Hemlibra was approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A with factor VIII inhibitors, Roche said.
The FDA's breakthrough therapy designation is designed to accelerate the development and review of drugs that treat serious conditions.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
Last year Hemlibra was approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A with factor VIII inhibitors, Roche said.
The FDA's breakthrough therapy designation is designed to accelerate the development and review of drugs that treat serious conditions.
Copyright (c) 2018 CercleFinance.com. All rights reserved.