CSL’s Hemgenix (etranacogene dezaparvovec) Receives EC’s Conditional Marketing Authorization for Hemophilia B
- The EC has granted CMA for Hemgenix in adults with sev. & moderately sev. hemophilia B without a history of Factor IX inhibitors
- The approval was based on the P-III trial (HOPE-B) results evaluating Hemgenix in 54 adult patients. The results showed a stable & durable increase in mean Factor IX activity levels with a mean Factor IX activity of 36.9%, leading to an ABR reduction of 64%, 96% discontinued routine Factor IX prophylaxis & 97% reduction in mean Factor IX consumption @18mos. post-treatment, was well-tolerated with no serious TRAEs
- The EC’s decision will be valid in all EU member states, incl. EEA countries of Iceland, Norway & Liechtenstein. Hemgenix’s submission is currently under MHRA review in the UK
Ref: PRNewswire | Image: CSL
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