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Pfizer’s Gene Therapy Asset Chases UniQure/CSL’s Hemgenix After Pivotal Hemophilia B Success

 
• By Ayisha Sharma

Pfizer’s fidanacogene elaparvovec has hit the mark in a Phase III hemophilia B trial just a month after rival UniQure’s Hemgenix won US approval, with Pfizer’s plans for regulatory action raising the stakes for Hemgenix.  

Two racing cars driving head to head, race concept
Pfizer Is Catching Up With UniQure In The Race To Market • Source: Shutterstock

Pfizer Inc. is set to challenge uniQure N.V./CSL Limited’s Hemgenix after the former’s adeno-associated virus (AAV)-based gene therapy asset for hemophilia B passed a Phase III trial, sparking plans for talks with regulators next year.

The BENEGENE-2 trial set Pfizer’s candidate, fidanacogene elaparvovec, against Factor IX (FIX) prophylaxis in 45 adult males with moderately severe to severe forms of hemophilia B, a rare blood disorder

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