Jacques LOIC/Photononstop via Getty Images The EU drug regulator, the European Medicines Agency (EMA), announced Friday that an expert panel of the agency backed Durveqtix (fidanacogene elaparvovec), developed by Pfizer ( NYSE: PFE ), as a gene therapy for certain adults with bleeding disorder hemophilia B. Issuing a so-called positive opinion, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a conditional marketing authorization for the one-time infusion. The CHMP recommendation, backed by data from an ongoing open-label, phase 3 trial for Durveqtix, will next be reviewed by the European Commission (EC) before a final decision on its marketing authorization.
If authorized, certain EU adults with severe and moderately severe hemophilia B will be eligible to receive Durveqtix, as opposed to the frequent and lifelong intravenous infusions that most patients in the region were subject to treat their bleeding episodes. More on Pfizer Pfizer: The Chart Looks Like A Bottom, But Is The Dividend Safe? Pfizer: Turning The Corner (Rating Upgrade) Pfizer: Down To A Historically Low Valuation - Is It A Buy? Third human bird flu case found in U.S.
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