Sanofi's multiple sclerosis med tolebrutinib may be under a partial FDA clinical hold after reports of liver injury in a handful of phase 3 studies, but that is not stopping the French pharma from collecting some data to make the case for efficacy and safety.
The relapsing MS trials in the tolebrutinib clinical trial program, GEMINI I and GEMINI II, are now fully enrolled. Regulatory timelines for this indication remain unchanged with submission in relapsing MS expected in 2024.
The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.
About 11% of Sanofi’s study sites for its MS molecule tolebrutinib are in Ukraine and Russia, John Reed, global head of research and development, said on an April 28 earnings call.