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| Press Release
Related News:- Roche’s Reports the US FDA’s Approval of Itovebi as a Treatment for HR+ and HER2- breast cancer with a PIK3CA mutation
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
