Roche: EU backs Hemlibra for haemophilia A indication
(CercleFinance.com) - European regulators have issued a positive opinion for Roche's Hemlibra for routine prophylaxis of bleeding episodes in people with haemophilia A with inhibitors, the Swiss drugmaker said late on Friday.
Hemlibra is being reviewed under accelerated assessment, a procedure granted to medicines that the EU Committee for Medicinal Products for Human Use (CHMP) believes are of major interest for public health and innovation, the firm said.
A final decision regarding the drug's approval is expected from the European Commission "in the near future," Roche said.
Hemlibra has already been approved in the United States for people with haemophilia A with factor VIII inhibitors.
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Hemlibra is being reviewed under accelerated assessment, a procedure granted to medicines that the EU Committee for Medicinal Products for Human Use (CHMP) believes are of major interest for public health and innovation, the firm said.
A final decision regarding the drug's approval is expected from the European Commission "in the near future," Roche said.
Hemlibra has already been approved in the United States for people with haemophilia A with factor VIII inhibitors.
Copyright (c) 2018 CercleFinance.com. All rights reserved.