Posted by Michael Wonder on 26 Mar 2025
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
25 March 2025 - Tolebrutinib was granted breakthrough therapy designation by the FDA based on positive results from the HERCULES Phase 3 study in adults with non-relapsing secondary progressive multiple sclerosis.
The US FDA is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis and to slow disability accumulation independent of relapse activity in adult patients.
