Shots:
- The US FDA has accepted sBLA & granted priority review to Hympavzi for the treatment of pts (≥6yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B without inhibitors (PDUFA: Q2’26)
- sBLA for Hympavzi (SC, QW) in adults & adolescents was supported by data from the inhibitor cohort (n=48) of P-III (BASIS) trial, while submission for children with or without inhibitors was backed by P-III (BASIS KIDS) trial (n=68)
- Hympavzi received the US FDA’s BTD for routine prophylaxis in pediatric hemophilia B pts (6 to <12yrs.) with or without inhibitors, while its use in pts (≥12yrs.) with hemophilia A or B with inhibitors is under review by the EMA
Ref: Pfizer | Image: Pfizer | Press Release
Related News: Pfizer Reports P-IIb (VESPER-3) Trial Results on PF’3944 in Weight Management
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
