Victory! FDA approves Pfizer’s hemophilia A or B monoclonal antibody drug Marstacimab

October 15, 2024  Source: drugdu 32

"/Pfizer - after starting a showdown with a radical investor, being betrayed by two former executives, reuniting with two former executives, and ending work on an RSV drug - finally has some good news, straightforward.

On Friday, the FDA approved Pfizer's hemophilia A or B drug Marstacimab, which will be sold under the Hympavzi brand. This therapy is an anti tissue factor pathway inhibitor that helps hemophilia patients form blood clots to limit their bleeding episodes.

A Pfizer spokesperson stated in an email to Endpoint News that the wholesale procurement cost for this weekly drug is $795600 per year, which is consistent with the WAC pricing for available prophylactic treatments for hemophilia A or B. It plans to start selling this drug this quarter.

This drug is packaged as a pre filled automatic injection pen, which analysts say can help it find a place in the market.

Given the maturity of factor replacement and the moderate improvement of Mastacrolizumab compared to conventional prevention, Pfizer will have to rely to some extent on the argument of convenience to gain traction, "TD Cowen analyst wrote in a report to investors during the American Society of Hematology meeting in December last year.

The FDA approves Hympavzi for routine prophylaxis to prevent or reduce bleeding events in adults and children as young as 12 years old. It is suitable for hemophilia A patients without factor VIII inhibitors or hemophilia B patients without factor IX inhibitors.

It will increase Pfizer's product portfolio in rare blood diseases. In April, the FDA approved the manufacturer's hemophilia B gene therapy Beqvez. Pfizer also plans to request approval for a hemophilia A gene therapy after touting phase 3 results in July, but it may face difficult commercialization due to the challenges BioMarin faces with its drug Roctavian.

By editor
Share: 

your submission has already been received.

OK

Subscribe

Please enter a valid Email address!

Submit

The most relevant industry news & insight will be sent to you every two weeks.