Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors
Shots:
- The US FDA has approved Alhemo injection (QD) as a prophylactic treatment to reduce the frequency of bleeding episodes in hemophilia A or B patients (≥12yrs.) with inhibitors
- Approval was based on the P-III (explorer7) study assessing Alhemo's efficacy and safety by comparing annual bleeding rates (ABR) in patients aged 12+ with hemophilia A or B with inhibitors
- Sudy showed Alhemo reduced annual bleeding rates (ABR) by 86%, with mean ABR of 1.7 vs 11.8. The overall median ABR was 0 vs 9.8 without prophylaxis, and 64% of patients on Alhemo had no spontaneous and traumatic bleeds in the first 24wks., vs 11% without prophylaxis
Ref: Novo Nordisk | Image: Novo Nordisk
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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.