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# Breakthrough Therapy Designation for Efanesoctocog Alfa
- URL: https://www.fdaweb.com/breakthrough-therapy-designation-for-efanesoctocog-alfa/
- Published: 2022-06-01T12:00:00.000Z
- Updated: 2026-09-14T17:46:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151950

FDA has granted breakthrough therapy designation to Sanofi’s efanesoctocog alfa to treat people with hemophilia A. A company [statement](https://www.sanofi.com/en/media-room/press-releases/2022/2022-06-01-07-00-00-2453803?ref=fdaweb.com) says efanesoctocog alfa is the first factor VIII therapy to receive the designation. Sanofi says the designation was based on the XTEND-1 Phase 3 study that demonstrated a clinically meaningful prevention of bleeds and superiority in preventing bleeding episodes compared to prior prophylaxis factor treatment.