FDA Issues Complete Response Letter For Sanofi's Tolebrutinib In NrSPMS Review

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(RTTNews) - Sanofi (SNY, SAN.PA) announced that the U.S. Food and Drug Administration has issued a complete response letter (CRL) for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) in adult patients.

"We are very disappointed by the FDA's action. ... We believe that the FDA should also take the advice of scientific experts, clinicians, and patients in this matter to ensure all perspectives are considered. We remain committed to working with the FDA to find a path forward for tolebrutinib and ultimately serve the MS community," said Houman Ashrafian, Executive Vice President, Head of Research & Development at Sanofi.

Tolebrutinib is an investigational, oral, brain-penetrant Bruton's tyrosine kinase inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in multiple sclerosis.

On December 15, 2025, Sanofi stated that it anticipated the US regulatory review process for tolebrutinib in nrSPMS would extend beyond the target action date of December 28, 2025. The company expected further guidance from the FDA by the end of the first quarter of 2026. In response to an FDA request, Sanofi submitted an expanded access protocol for tolebrutinib in nrSPMS.

As previously communicated on December 15, 2025, Sanofi is conducting an impairment test in accordance with IFRS (IAS 36) on the intangible asset value associated with tolebrutinib. The results of this test will be disclosed with the company's fourth quarter and fiscal year 2025 financial results in January 2026. Sanofi confirmed that the outcome of the test will not affect business net income or business earnings per share, and its financial guidance for 2025 remains unchanged.

Tolebrutinib was provisionally approved in the United Arab Emirates in July 2025 for the treatment of non-relapsing secondary progressive multiple sclerosis and to slow disability accumulation independent of relapse activity in adults. It is currently under regulatory review in the EU and other jurisdictions worldwide.

SNY closed regular trading at $48.32 on December 23, 2025, up $0.29 or 0.60%. The stock remained flat in after-hours trading.

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