Sanofi(US:SNY) Globenewswire·2025-12-24 06:00Core Viewpoint - Sanofi's tolebrutinib, an investigational treatment for non-relapsing secondary progressive multiple sclerosis (nrSPMS), has received a complete response letter (CRL) from the FDA, indicating a significant setback in its regulatory submission process [1][3]. Regulatory Update - The FDA's review of tolebrutinib is expected to extend beyond the previously set target action date of December 28, 2025, with further guidance anticipated by the end of Q1 2026 [2]. - Sanofi has submitted an expanded access protocol for tolebrutinib in response to an FDA request [2]. Company Response - Sanofi expressed disappointment regarding the FDA's decision, emphasizing the unmet medical need for addressing disability progression in MS and the previous breakthrough therapy designation awarded to tolebrutinib [3]. - The company remains committed to collaborating with the FDA to find a path forward for tolebrutinib [3]. Product Information - Tolebrutinib is designed as an oral, brain-penetrant Bruton's tyrosine kinase inhibitor targeting neuroinflammation, which is a key factor in disability progression in MS [6]. - The drug was provisionally approved in the UAE in July 2025 for treating nrSPMS and is under review in the EU and other regions [4]. Financial Considerations - Sanofi is conducting an impairment test on the intangible asset value of tolebrutinib, with results expected to be reported alongside Q4 and FY 2025 results in January 2026 [5]. - The outcome of this test will not affect the company's net income or earnings per share, and there is no change to the financial guidance for 2025 [5]. Commitment to Innovation - Tolebrutinib reflects Sanofi's dedication to developing innovative treatments for neurological diseases, aiming to transform the treatment landscape for conditions like MS and other neurodegenerative disorders [7].