Updated: FDA approves Pfizer’s hemophilia B gene therapy, with $3.5M price tag

Pfiz­er an­nounced Fri­day morn­ing that the FDA ap­proved its gene ther­a­py for the rare ge­net­ic bleed­ing dis­or­der he­mo­phil­ia B.

The one-time treat­ment, known gener­i­cal­ly as fi­danaco­gene ela­parvovec, is in­di­cat­ed for adults with mod­er­ate-to-se­vere he­mo­phil­ia B. The phar­ma com­pa­ny will mar­ket the gene ther­a­py as Be­qvez. The treat­ment was first ap­proved in Cana­da in Jan­u­ary.

It’s the sec­ond gene ther­a­py ap­proved for he­mo­phil­ia B, af­ter CSL re­ceived a reg­u­la­to­ry nod for Hem­genix in 2022. Pfiz­er said Fri­day that it would price its ther­a­py at $3.5 mil­lion, the same amount as Hem­genix.

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