Pfizer, Inc. (NYSE: PFE) today announced that the FDA has accepted a biologics license application (BLA) for fidanacogene elaparvovec, its gene therapy for the treatment of hemophilia B in adults, with a final date for review in the second quarter of 2024. Meanwhile, the European Marketing Authorisation application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA). Fidanacogene elaparvovec is a novel investigational gene therapy containing highly active variants of the bioengineered adeno-associated virus (AAV) capsid (protein shell) and FIX genes. The goal of the therapy is to allow patients to produce FIX on their own with a one-time treatment, without the need for regular intravenous FIX injections.

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