Pfizer withdraws fidanacogene elaparvovec globally

Pfizer has decided to terminate the development and commercialization of its hemophilia B gene therapy fidanacogene elaparvovec (marketed as Beqvez) globally, resulting in the withdrawal of its regulatory filing in Japan, and suspension of appraisals in the UK.

The product was supposed to be reviewed for approval by the Pharmaceutical Affairs Council’s Committee on Regenerative Medicine Products, Biological Products and Biotechnologies in Japan . However, it disappeared from the meeting agenda because its regulatory application was withdrawn before the session.

The company decided to withdraw the therapy due to limited interest from patients and clinicians, with no patients having received the treatment commercially