Posted by Michael Wonder on 24 Dec 2025
Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis
24 December 2025 - The US FDA has issued a complete response letter for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis in adult patients.
On December 15, 2025, Sanofi provided an update on the ongoing review which stated that: (i) FDA was expecting the review to go beyond the previously communicated revised US target action date of 28 December 2025; (ii) further guidance from the FDA was expected by the end of the first quarter of 2026; and (iii) in response to an FDA request, Sanofi had submitted an expanded access protocol for tolebrutinib in non-relapsing secondary progressive multiple sclerosis.
