Sanofi’s MS Candidate Tolebrutinib On Clinical Hold Following Liver Toxicities

Sanofi has hit a regulatory road bump as the US FDA placed its MS candidate tolebrutinib on clinical hold following concerns over liver toxicities, but strong enrollment numbers mean impact on studies should be limited.

The US Food and Drug Administration placed a partial clinical hold on Phase III studies of tolebrutinib in multiple sclerosis (MS) and generalized myasthenia gravis (gMG) following several reports of drug-induced liver injuries in these trials