Pfizer Reports the US FDA’s Approval of Hympavzi to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents
Shots:
- The US FDA has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively. It has also received the CHMP’s positive opinion for the same
- Results from pivotal P-III (BASIS) study, assessing Hympavzi in patients (12-75yrs.) with severe hemophilia A or mod. severe to severe hemophilia B with/without inhibitors, formed the basis of approval
- Study depicted a reduction in the annualized bleeding rate (ABR) by 35% & 92% post 12mos. with Hympavzi vs routine prophylaxis & on-demand treatment. Safety was similar to the outcomes of P-I/II study, with most common AEs being injection site reactions, headache & pruritus
Ref: Pfizer | Image: Pfizer
Related News:- Pfizer Reports the EC’s Conditional Approval of Durveqtix (Fidanacogene Elaparvovec) for the Treatment of Hemophilia B
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
