Abivax Advances NDA Plans for Obefazimod Following Positive FDA Meeting
Friday, July 31, 2026
Abivax has completed a positive pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) for obefazimod, its investigational treatment for adults with moderately to severely active ulcerative colitis (UC).
The company said the discussions resulted in agreement with the FDA on its planned NDA submission strategy, including the proposed content and format of the application. The regulatory feedback supports Abivax’s preparations for its first NDA submission for obefazimod.
Abivax remains on schedule to submit the NDA by the end of 2026.
The milestone follows the positive Phase III ABTECT programme results announced earlier this year, which continue to support the potential of obefazimod as a treatment for ulcerative colitis. The company expects the latest FDA guidance to help streamline the final stages of the submission process.
Source: globenewswire.com
