Pfizer's Hympavzi Receives FDA Priority Review for Haemophilia

Pfizer Inc. announced today that the FDA has granted Priority Review for its supplemental Biologics License Application (sBLA) for Hympavzi (marstacimab).

The approval aims at extending its indication to include haemophilia A or B patients, ages 6 and above, with inhibitors; and pediatric patients (ages 6-11) with haemophilia A or B, without inhibitors. Hympavzi is currently authorized to treat patients with haemophilia A or B with or without inhibitors and 12 years old and above.

In the second quarter of 2026, the FDA has issued a PDUFA action date. Assuming approval, Hympavzi would provide these patients with the protection of using bleed with only one weekly subcutaneous injection at minimal preparation and no regular lab checks. It has a potential to significantly enhance the life of individuals with haemophilia that is not easily treated.

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“There is a significant medical need for younger patients with haemophilia and for those who have developed inhibitors, which neutralize factor replacement therapies and render them ineffective,” said Michael Vincent, M.D., Ph.D., Chief Inflammation & Immunology Officer at Pfizer.

Hympavzi is also designated as Breakthrough Therapy by the FDA in the treatment of paediatric patients aged 6 to less than 12 with haemophilia B in addition to Priority Review. This title will speed up the process of coming up with cures to severe ailments.

Hympavzi has shown good outcomes based on BASIS and BASIS KIDS trials; hence it is a promising therapy to patients that have limited treatments in modern times.