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 

• Study showed Alhemo reduced annual bleeding rates (ABR) by 86%, with a 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 | Press Release

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