EMA Speeds Approval Process for Hemophilia B Gene Therapy

EMA Speeds Approval Process for Hemophilia B Gene Therapy

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EMA Speeds Approval Process for Hemophilia B Gene Therapy

The European Medicines Agency (EMA) has approved an accelerated assessment request for etranacogene dezaparvovec, an experimental gene therapy for hemophilia B. The decision means that, once an application is submitted seeking approval for marketing authorization of etranacogene dezaparvovec, it will be reviewed more quickly than normal — which could allow patients in Europe to access the therapy sooner, according to a press release. The EMA grants accelerated assessment to products that are expected to be of…

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