Sanofi’s Tolebrutinib Phase 3 Clinical Trial Paused Globally After FDA Clinical Hold
Sanofi said that its phase 3 studies investigating tolebrutinib have been paused globally at the recommendation of the independent data monitoring committee.
The recommendation follows a partial clinical hold the FDA had placed on the company’s phase 3 clinical trials investigating tolebrutinib in participants with multiple sclerosis and myasthenia gravis following several reports of drug-induced liver injury.
Tolebrutinib is an investigational brain-penetrant and bioactive Bruton’s tyrosine kinase inhibitor that modulates the activity of B lymphocytes and microglial cells.
Sanofi said it plans to submit additional information the FDA requested by the end of September.
August 12, 2022
