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bluebird bio’s BLA for lovo-cel Gets FDA Priority Review

Lovo-cel is a one-time gene therapy specifically designed to treat the underlying cause of sickle cell disease.

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By: Kristin Brooks

Managing Editor, Contract Pharma

bluebird bio, Inc.’s BLA for lovotibeglogene autotemcel (lovo-cel) has been accepted for priority review by U.S. FDA. Lovo-cel is a one-time gene therapy for individuals with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events (VOEs). It’s specifically designed to treat the underlying cause of SCD through the addition of a functional gene that enables production of anti-sickling adult hemoglobin. The agency has set a Prescription Drug User Fee Act (PDUFA) goal...

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