Posted by Michael Wonder on 22 Sep 2025
Update on the US regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis
22 September 2025 - The US FDA has extended by three months the target action date of its review of the new drug application of tolebrutinib, an oral and brain penetrant investigational Bruton's tyrosine kinase inhibitor to treat non-relapsing, secondary progressive multiple sclerosis and to slow disability accumulation independent of relapse activity in adult patients.
Based on the submission of additional analyses during the review, the FDA has determined that the additional information constituted a major amendment to the new drug application and extended the target action date accordingly. The revised target action date for the FDA decision is 28 December 2025.
