Roche: FDA grants fast review to hemophilia drug Hemlibra
(CercleFinance.com) - Roche on Tuesday said US regulators have granted a priority review for the company's Hemlibra for adults and children with haemophilia A without factor VIII inhibitors.
The designation means that the US Food and Drug Administration is expected to make its decision on the drug's marketing application by October 2018.
Hemlibra was approved by the FDA in November 2017 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.
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The designation means that the US Food and Drug Administration is expected to make its decision on the drug's marketing application by October 2018.
Hemlibra was approved by the FDA in November 2017 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.
Copyright (c) 2018 CercleFinance.com. All rights reserved.