{"id":64027,"date":"2026-04-27T14:42:26","date_gmt":"2026-04-27T06:42:26","guid":{"rendered":"https:\/\/flcube.com\/?p=64027"},"modified":"2026-04-27T14:42:27","modified_gmt":"2026-04-27T06:42:27","slug":"sanofi-secures-chmp-positive-opinion-for-cenrifki-tolebrutinib-in-non-relapsing-spms-despite-fda-complete-response-letter-setback","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64027","title":{"rendered":"Sanofi Secures CHMP Positive Opinion for Cenrifki (Tolebrutinib) in Non-Relapsing SPMS Despite FDA Complete Response Letter Setback"},"content":{"rendered":"\n

Sanofi<\/strong> (NASDAQ: SNY<\/a>) announced on 24 April 2026<\/strong> that the European Medicines Agency\u2019s Committee for Medicinal Products for Human Use (CHMP)<\/strong> has issued a positive opinion<\/strong> recommending approval of Cenrifki\u2122 (tolebrutinib)<\/strong> for the treatment of secondary progressive multiple sclerosis (SPMS)<\/strong> in adults with no relapses in the past two years<\/strong>.<\/p>\n\n\n\n

The recommendation\u2014based on the Phase III HERCULES trial<\/strong>\u2014positions tolebrutinib as a potential first-in-class brain-penetrant Bruton\u2019s tyrosine kinase (BTK) inhibitor<\/strong> targeting smoldering neuroinflammation<\/strong>, a key driver of irreversible disability in progressive MS. A final EU marketing authorization decision is expected in the coming months.<\/p>\n\n\n\n

Notably, this European advance contrasts with a U.S. regulatory setback<\/strong>: the FDA issued a Complete Response Letter (CRL)<\/strong> for the same indication in December 2025<\/strong>, though Sanofi has not disclosed specific deficiencies.<\/p>\n\n\n\n

Clinical & Regulatory Profile<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Drug<\/strong><\/td>Cenrifki\u2122 (tolebrutinib) \u2013 oral, brain-penetrant BTK inhibitor<\/td><\/tr>
Indication<\/strong><\/td>Non-relapsing secondary progressive MS (SPMS)<\/td><\/tr>
Mechanism<\/strong><\/td>Inhibits BTK in CNS-resident immune cells to suppress chronic neuroinflammation<\/td><\/tr>
Pivotal Trial<\/strong><\/td>HERCULES Phase III \u2013 demonstrated significant delay in confirmed disability progression<\/strong><\/td><\/tr>
EU Status<\/strong><\/td>CHMP positive opinion (final EC decision pending)<\/td><\/tr>
U.S. Status<\/strong><\/td>CRL received Dec 2025; resubmission timeline undisclosed<\/td><\/tr>
Unmet Need<\/strong><\/td>No approved therapies specifically for non-relapsing SPMS; current options limited to symptom management<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Disease Context: The Burden of SPMS<\/h2>\n\n\n\n