Sanofi SA said Thursday that the Food and Drug Administration has paused some U.S.-based Phase 3 trials of drug tolebrutinib for treatment of multiple sclerosis and the muscle-weakness condition myasthenia gravis.
The U.S. regulator based its actions on a limited number of drug-induced liver injury cases, the French pharmaceutical company said.
Sanofi said new enrollments in the U.S. have been paused, and those who have taken part in the trial for fewer than 60 days will stop taking the drug.
Patients who have completed at least 60 days in the studies should continue treatment, Sanofi said.
The majority of affected patients were found to have pre-existing conditions that made them predisposed to drug-induced liver injuries, which were reversible after discontinuing the drug, the company said.
Study enrollment outside of the U.S. continues with revised study protocols and safety monitoring, Sanofi said.
The company said it is still confident in tolebrutinib's potential as an oral treatment for multiple sclerosis.
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