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Roche says FDA grants priority review to hemophilia drug emicizumab
August 24, 2017 / 5:22 AM / a month ago

Roche says FDA grants priority review to hemophilia drug emicizumab

ZURICH (Reuters) - Swiss pharma group Roche said the U.S. Food and Drug Administration (FDA) granted priority review to its emicizumab for hemophilia A with inhibitors.

The application is based on positive results of a phase III study in adolescents and adults with hemophilia A with inhibitors and interim phase III results in children, Roche said in a statement on Thursday.

The FDA is expected to make a decision on approval by February 23, 2018, Roche said, adding that nearly a third of hemophilia A patients developed inhibitors limiting treatment options and increasing the risk of life-threatening bleeds.

Reporting by Silke Koltrowitz; editing by Brenna Hughes Neghaiwi

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