Shots:
- The US FDA has approved label expansion of Alhemo (concizumab-mtci) to prevent or reduce the frequency of bleeding episodes in pts (≥12yrs.) with HA/HB without inhibitors
- Approval was based on P-III (Explorer8) trial assessing Alhemo (n=42, 1mg/kg followed by 0.2mg/kg QD) vs no prophylaxis (n=21) in 156 males with HA/HB, where median duration of treatment was 32.1 & 24.1wks., respectively
- Trial showed a 79% & 86% ABR reduction in HB & HA, respectively, with average ABRs of 3.1 vs 14.8 for HB & 2.7 vs 19.3 for HA as well as median ABR of 1.6 vs 14.9 for HB & 2.9 vs 19.6 for HA
Ref: PRNewsWire | Image: Novo Nordisk | Press Release
Related News:- Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors
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