Pfizer Secures FDA Priority Review for HYMPAVZI Expansion, TrumpRx Launch Discounts
FDA grants Priority Review to HYMPAVZI sBLA for treatment expansion to hemophilia A/B patients aged six and older with inhibitors and pediatric patients without inhibitors, with a PDUFA action date in Q2 2026. Pfizer also launched TrumpRx offering discounts on over 30 medicines to reduce patient costs.
1. FDA Grants Priority Review for HYMPAVZI
Pfizer’s supplemental Biologics License Application for HYMPAVZI (marstacimab) to treat hemophilia A or B patients aged six and older with inhibitors and pediatric patients without inhibitors received FDA Priority Review, with a user fee goal date set in Q2 2026. If approved, once-weekly subcutaneous injections could expand treatment options without routine lab monitoring.
2. Launch of TrumpRx Discount Program
Pfizer launched the TrumpRx initiative on February 5, providing significant list-price discounts on over 30 medicines. The program aims to improve affordability for cash-paying patients and aligns with the company’s broader Most Favored Nation agreement with the US government.