FDA accepts bluebird bio's lovo-cel BLA for priority review

Following earlier regulatory setbacks, the US Food and Drug Administration (FDA) has now accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review, the drug’s developer, bluebird bio (Nasdaq: BLUE), revealed yesterday.

Market reaction was positive at first, lifting the biotech’s shares around 5% pre-market, but the stock was down 4.25% at $3.35 by late morning on Wednesday.

Bluebird says that lovo-cel is a potentially transformative one-time gene therapy for individuals living with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events (VOEs). It is specifically designed to treat the underlying cause of SCD through the addition of a functional gene that enables production of anti-sickling adult hemoglobin and is the most deeply studied gene therapy in development for this disease. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.