CSL’s Hemgenix (etranacogene dezaparvovec) Receives EC’s Conditional Marketing Authorization for Hemophilia B
Shots:
- 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
Related Post:- CSL’s Hemgenix (etranacogene dezaparvovec-drlb) Receives the US FDA’s Approval for the Treatment of Hemophilia B
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
