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# Priority Review for Sanofi’s Efanesoctocog Alfa
- URL: https://www.fdaweb.com/priority-review-for-sanofis-efanesoctocog-alfa/
- Published: 2022-08-30T12:00:00.000Z
- Updated: 2026-09-14T17:57:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152620

FDA has accepted for priority review a Sanofi BLA for efanesoctocog alfa to treat hemophilia A. The agency set a PDUFA action date of 2/28/23 for its decision on the BLA, the company [says](https://www.sanofi.com/en/media-room/press-releases/2022/2022-08-30-05-30-00-2506359?ref=fdaweb.com).

Sanofi says the BLA was supported by data from the pivotal XTEND-1 Phase 3 study that it says demonstrated a clinically meaningful prevention of bleeds and superiority to prior factor prophylaxis based on an intra-patient comparison.

Efanesoctocog alfa is described as a novel and investigational recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for people with hemophilia A.