Roche: emicizumab gets positive results in haemophilia.
(CercleFinance.com) - Roche said on Monday that positive phase III results for its investigational monoclonal antibody emicizumab in haemophilia A were published in The New England Journal of Medicine.
The study showed a clinically meaningful and statistically significant reduction in treated bleeds amounting to 87%, the Swiss biopharmaceutical company said, along with a bleed rate reduction of 79% compared to prior prophylactic bypassing agents.
Data from the trials has hence been submitted for approval consideration to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), Roche said.
For the record, the FDA granted the drug a "breakthrough therapy designation" in adults and adolescents with haemophilia A with inhibitors in September 2015.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
The study showed a clinically meaningful and statistically significant reduction in treated bleeds amounting to 87%, the Swiss biopharmaceutical company said, along with a bleed rate reduction of 79% compared to prior prophylactic bypassing agents.
Data from the trials has hence been submitted for approval consideration to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), Roche said.
For the record, the FDA granted the drug a "breakthrough therapy designation" in adults and adolescents with haemophilia A with inhibitors in September 2015.
Copyright (c) 2017 CercleFinance.com. All rights reserved.