Abivax Advances with FDA on Obefazimod for Ulcerative Colitis

Abivax SA, a biotechnology company focused on chronic inflammatory diseases, announced a successful pre-New Drug Application (NDA) interaction with the FDA for its drug candidate obefazimod. This development aligns the company's NDA submission strategy for treating moderate to severe ulcerative colitis in adults.

The company plans to submit its first NDA for obefazimod by the end of 2026. CEO Marc de Garidel highlighted this alignment as a key milestone, following positive Phase 3 ABTECT program results. These results reinforce obefazimod's potential in treating ulcerative colitis.