Abivax receives positive feedback from the FDA for obefazimod

Abivax announced that the U.S. Food and Drug Administration (FDA) has given positive feedback following pre-submission discussions regarding its New Drug Application (NDA) for obefazimod. This treatment is intended for adults with moderately to severely active ulcerative colitis. The company is on track to submit this application by the end of 2026.

Abivax CEO Marc de Garidel emphasized the importance of this alignment with the FDA. This follows the positive results of the Phase 3 trial of the ABTECT program. The company is now working to finalize the regulatory submission for obefazimod, further solidifying its position in the field of immunomodulatory therapies.