Pfizer Announces FDA Approval of Marstacimab (HYMPAVZI) for Prophylaxis in Hemophilia A and B

Oct 13, 2024 09:45 CST Updated 09:45

Pfizer

Pharmaceutical R&D Developer

▲October 26-27, Chengdu
China Clinical Trials Industry Development ConferenceClick for FreeRegistration

Note:This article does not constitute any investment opinions or suggestions., subject to official/company announcements;This article only introduces drugs related to medical health, not a recommendation of treatment options (if involved), and does not represent the platform's position.Any article reprinted needs to be authorized.

Pfizer —— After a showdown with an activist investor, betrayal by two former executives, a reunion with those same executives, and the termination of work on an RSV drug — finally has some straightforward good news.

Friday,FDA Approves Pfizer's Marstacimab for Hemophilia A or B, the drug will be sold under the brand name Hympavzi. The therapy is an anti-tissue factor pathway inhibitor that helps hemophilia patients form blood clots to limit their bleeding episodes.

A Pfizer spokesperson said in an email to Endpoints News that the wholesale acquisition cost of this once-a-week drug is$795,600"This is consistent with the WAC pricing for preventive treatments for Hemophilia A or B currently available on the market." It plans to begin selling the drug this quarter.

This drug is packaged in a pre-filled auto-injector pen, and analysts say this could help it carve out a niche in the market.

"Given that factor replacement is already mature and the improvement of marstacimab over conventional prophylaxis is modest, Pfizer will have to rely to some extent on the convenience argument to gain traction," TD Cowen analysts wrote in a report to investors during the American Society of Hematology conference last December.

FDA Approves Hympavzi for Routine Prophylaxis to Prevent or Reduce Bleeding Episodes 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 expand Pfizer's portfolio in rare blood disorders.In April, the FDA approved the pharmaceutical company's hemophilia B gene therapy Beqvez.Pfizer plans to seek approval for a hemophilia A gene therapy after touting the phase 3 results in July, but it may face tough commercialization challenges given the difficulties BioMarin has encountered with its drug Roctavian.

Copyright statement: This article is reproduced from the Biopharmaceutical Era,Media or individuals who do not wish to be reprinted can contact us, and we will delete it immediately.