European CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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Roche’s first-in-class one-dose antiviral Xofluza has been approved for marketing in the EU to treat influenza in patients aged 12 years or over, and for post-exposure prophylaxis.
Strong top-line efficacy in pyruvate kinase deficiency patients who don’t receive regular transfusions looks approvable, analysts say, but Agios will await data in regularly transfused patients.
BioMarin plans to resubmit its marketing application for Roctavian to the European Medicines Agency.