Novo Nordisk: submits applications for haemophilia A therapy
(CercleFinance.com) - Danish diabetes drug maker Novo Nordisk said on Tuesday it has submitted a regulatory filing to the US and the EU for a new treatment of haemophilia A.
The firm announced the submission of a biologics license application to the US Food and Drug Administration (FDA) and a marketing authorisation application to the European Medicines Agency (EMA) for N8-GP.
The submission is based on results from a clinical trial that included over 250 people with haemophilia A, showing an average bleeding rate of 1.3 episodes compared to 30.9 episodes for people treated on-demand, Novo Nordisk said.
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The firm announced the submission of a biologics license application to the US Food and Drug Administration (FDA) and a marketing authorisation application to the European Medicines Agency (EMA) for N8-GP.
The submission is based on results from a clinical trial that included over 250 people with haemophilia A, showing an average bleeding rate of 1.3 episodes compared to 30.9 episodes for people treated on-demand, Novo Nordisk said.
Copyright (c) 2018 CercleFinance.com. All rights reserved.