Shots:
- The US FDA has approved Pfizer‘s Hympavzi for the treatment of pts (≥12yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B with or without inhibitors
- Approval of Hympavzi (SC, QW) in pts (≥12yrs.) was supported by the P-III (BASIS) trial, showing improved key bleeding outcomes incl. reduced mean treated ABR by 93% vs on-demand (OD) IV treatment with bypassing agents
- Approval of Hympavzi ± inhibitors was backed by interim P-III (BASIS KIDS) data, where Hympavzi reduced treated ABR to 1.8 vs 3.6 with routine prophylaxis (- inhibitors) & 1.4 vs 18.9 with OD therapy (+ inhibitors) in pts (6-17yrs.). In pts (6-11yrs.), model-based mean treated ABRs were 1.4 & 1.3, respectively, with median ABRs of 1 across groups
Ref: Pfizer | Image: Pfizer |Press Release
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