Abivax aligned with the FDA on its NDA strategy for obefazimod, keeping the ulcerative colitis therapy on track for a U.S. filing by the end of 2026.
Written By: Umesh Hanumante,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Abivax has completed a positive pre-New Drug Application (NDA) interaction with the U.S. Food and Drug Administration (FDA) for obefazimod, its investigational therapy for adults with moderately to severely active ulcerative colitis (UC). The agency provided constructive feedback that aligned with the company’s proposed NDA submission strategy, including the planned content and format of the application. The outcome keeps Abivax on track to submit its first NDA for obefazimod by the end of 2026.
Regulatory Milestone Clarifies the Path to Submission
A pre-NDA meeting allows the FDA and a sponsor to review the readiness of a marketing application before formal submission. According to Abivax, the agency’s feedback confirmed key elements of the company’s filing strategy and provided alignment on the structure of the planned application.
The successful interaction represents an important regulatory milestone as Abivax prepares its first U.S. marketing application and moves obefazimod closer to potential commercialization.
Obefazimod and the Need for New Ulcerative Colitis Therapies
Obefazimod is a first-in-class oral small molecule that enhances the expression of microRNA-124 (miR-124), a naturally occurring regulator of inflammation. By increasing miR-124 levels, the therapy modulates multiple inflammatory pathways involved in chronic immune-mediated diseases.
Ulcerative colitis is a chronic inflammatory bowel disease characterized by persistent inflammation of the colon, causing symptoms such as rectal bleeding, diarrhea, abdominal pain, and urgency. Although biologics and targeted therapies have expanded treatment options, many patients continue to experience inadequate response, loss of efficacy over time, or treatment-related limitations, highlighting the need for additional oral therapies with durable clinical benefit.
Phase 3 Program Supports the Regulatory Filing
The planned NDA will be supported by data from the global Phase 3 ABTECT clinical program evaluating obefazimod in adults with moderately to severely active ulcerative colitis. Earlier this year, Abivax reported positive Phase 3 results that established the clinical foundation for the upcoming regulatory submission.
The company did not disclose additional efficacy or safety findings in the latest update, as the announcement focused on regulatory progress rather than new clinical data.
Executive Perspective
Marc de Garidel, Chief Executive Officer of Abivax, said the FDA’s constructive feedback marks an important milestone as the company prepares its first NDA submission. He added that the agency’s alignment provides confidence in the regulatory pathway and supports the company’s plan to complete the filing by the end of 2026.
Future Development
Abivax expects to submit its NDA for obefazimod by the end of 2026. If accepted for review, the application would mark the company’s transition toward becoming a commercial-stage biotechnology company in the United States.
An FDA acceptance of the application would also initiate the formal review process for obefazimod, potentially bringing a first-in-class oral treatment option closer to adults living with moderately to severely active ulcerative colitis.
Reference
Abivax Announces Positive Pre-NDA Interaction with the FDA for Obefazimod | Abivax
About the Writer
Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.