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Home Industry News Bayer files for European approval of haemophilia A therapy

Bayer files for European approval of haemophilia A therapy

11th September 2017

Bayer has announced that it has submitted an application for European marketing authorisation of its latest haemophilia A therapy BAY94-9027.

The long-acting site-specifically PEGylated recombinant human Factor VIII therapy will be assessed by the European Medicines Agency, with the regulatory submission based on the results from the PROTECT VIII trial.

In this trial, BAY94-9027 was shown to offer protection from bleeds with dosing intervals when used prophylactically once every seven days, once every five days, and twice per week.

It was also effective for controlling bleeding during surgical procedures, with the vast majority of events being resolved with one or two infusions.

Dr Joerg Moeller, member of the executive committee of Bayer's pharmaceutical division and head of development, said: "With this filing, we hope to make a significant contribution towards alleviating the impact of this disease in the future."

The company also submitted a biologics licence application for BAY94-9027 in this indication to the US Food and Drug Administration in August 2017.

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