Sanofi announced the withdrawal of its regulatory application in Europe for Dupixent (dupilumab) to treat adults with moderate-to-severe bullous pemphigoid. The decision was finalized on June 24, 2026, following a thorough evaluation by the European Medicines Agency (EMA). This withdrawal contrasts with the June 2025 approval of the same indication by the U.S. Food and Drug Administration.

The EMA determined that the potential risks of utilizing Dupixent for bullous pemphigoid outweighed its therapeutic benefits. The agency concluded that several critical issues remained unresolved despite Sanofi's responses to inquiries. Observed clinical improvements were described as minimal and accompanied by significant uncertainty.

Clinical Trial Shortfalls

The submission relied on a primary clinical trial encompassing 106 adult patients. Participants received either Dupixent or a placebo alongside standard oral corticosteroid treatments until their condition stabilized. The trial's primary goal was achieving sustained remission, defined as eliminating the need for corticosteroids by week 16, along with no disease relapse or need for rescue therapy by week 36.

The core clinical trial failed to meet this primary endpoint. Secondary outcomes lacked robustness due to limitations inherent in the study design. Additional supporting data from real-world use were deemed insufficient to validate the drug's efficacy for this specific ailment.

Regulatory Context

Bullous pemphigoid is an autoimmune skin condition characterized by extensive blistering and itching of the skin and occasionally of the mouth. Sanofi initially filed to expand Dupixent's indication for this disease but later narrowed the scope to target only moderate-to-severe cases during the review process. Dupixent is developed jointly by Sanofi and Regeneron Pharmaceuticals Inc.

What the Numbers Show

The divergence between U.S. and European regulatory outcomes highlights differing thresholds for evidence in rare autoimmune disorders. While the FDA approved the indication in June 2025, the EMA rejected it less than a year later based on the same primary trial data involving 106 patients. The failure to meet the primary endpoint of sustained remission without corticosteroids suggests that the drug's benefit-risk profile was not sufficiently established for the European market under current guidelines.

Sanofi India Limited secured a Goods and Services Tax (GST) refund of ₹1,32,93,535 following an order by the Deputy Commissioner of Central Goods & Service Tax in Goa. The authority accepted the company’s application to grant the refund without adjusting it against an existing tax demand.

The order, received by the company on August 12, 2026, specifically dropped the proposed adjustment of the refund amount against an outstanding demand of ₹75,63,190. This decision allows the full refund value to be processed independently of the pending liability.

Regulatory Disclosure Details

The disclosure was made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The key details of the regulatory action are outlined below:

Financial Impact

The company stated that there is no material impact on its financial, operational, or other activities resulting from this order. The disclosure was signed by Haresh Vala, Company Secretary and Compliance Officer, and filed with both the Bombay Stock Exchange and the National Stock Exchange of India Limited.