Pfizer Reports the EC’s Conditional Approval of Durveqtix (Fidanacogene Elaparvovec) for the Treatment of Hemophilia B
Shots:
- The EC has granted conditional marketing authorization to Durveqtix in severe & moderately severe hemophilia B adults not treated with factor IX inhibitors and absence of AAV Rh74 antibodies, applicable across the whole EU plus Iceland, Liechtenstein & Norway
- Approval was based on the P-III (BENEGENE-2) trial assessing the safety & efficacy of Durveqtix (IV, 5 x 10^11 vg/kg) to treat severe to moderately severe hemophilia B adult males (n=45; 18-65yrs.). Study compared ABR with gene therapy vs routine FIX prophylaxis
- Trial reached its 1EP, depicting a reduction in annualized bleeding rate (ABR); ABR was maintained from yr.2 to 4 post treatment. Safety aligned with that in P-I/II study
Ref: Pfizer | Image: Pfizer
Related News:- Pfizer Reports Topline Data from P-III Trial of Giroctocogene Fitelparvovec for Treating Hemophilia A
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
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.
