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Pfizer Inc.’s Beqvez (fidanacogene elaparvovec) won FDA approval for use in adults with hemophilia B, making it the second adeno-associated viral (AAV) vector-based gene therapy available for patients in the U.S., following the late 2022 approval of CSL Behring’s Hemgenix (etranacogene dezaparvovec).
The agency greenlighted the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B.
Teddi Shaw, a baby with extremely rare and fatal genetic disorder, becomes the first person in the UK to receive Libmeldy, a £2.8 million drug.
Synergie, a new independent company, aims to disrupt the specialty drug market by banding insurers together to negotiate prices for high-cost treatments such as gene therapy.