FDA Currently Denies Authorization for Sanofi's Tolebrutinib
Sanofi has received a complete response letter from the U.S. FDA regarding its application for marketing authorization of tolebrutinib in the treatment of non-relapsing secondary progressive multiple sclerosis. This decision comes after the agency had previously granted the drug candidate an innovative drug designation.
Complete Response Letter Issued
The Food and Drug Administration issued a complete response letter for the authorization request of tolebrutinib intended for the treatment of non-relapsing secondary progressive multiple sclerosis in adults, Sanofi announced in a statement on December 24, 2025. The pharmaceutical group described this decision as a significant shift from the agency's previous feedback. On December 15, 2025, the laboratory had specified that the regulatory review would continue beyond the target action date of December 28, 2025, and that new FDA guidance was expected before the end of the first quarter of 2026. At the request of the American agency, Sanofi had also submitted an expanded access protocol for tolebrutinib for this indication.
International Approvals and Ongoing Reviews
Tolebrutinib, an orally administered Bruton's tyrosine kinase inhibitor, received provisional approval in the United Arab Emirates in July 2025 for the treatment of non-relapsing secondary progressive multiple sclerosis and to slow the accumulation of disability independent of relapse activity in adults, according to the statement. The drug candidate is currently under regulatory review in the European Union and other jurisdictions worldwide. The experimental drug is designed to target neuroinflammation, a factor in the progression of disability in multiple sclerosis, the company specifies.
Financial Implications and Future Outlook
Sanofi is conducting an impairment test in accordance with IFRS standards on the intangible asset value related to tolebrutinib, with the status to be communicated along with the fourth quarter and full year 2025 results in January 2026, the group indicates. The outcome of this test will have no impact on the net result of operations or on the net earnings per share of operations, the company specifies. The financial outlook for 2025 remains unchanged, according to the statement. The laboratory declares it remains determined to work with the FDA to find a path forward for tolebrutinib.
