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Sanofi's Late-stage Studies Of Tolebrutinib In Multiple Sclerosis And Myasthenia Gravis Put On Hold

Sanofi (SNY) on Thursday said that the U.S. Food and Drug Administration (FDA) has put partial clinical hold on Phase 3 studies of tolebrutinib in multiple sclerosis (MS) and myasthenia gravis due to some cases of drug-induced liver injury found in patients enrolled in these studies .

Consequently, new enrollment in these studies is paused and participants who have been in the study for less than 60 days will suspend study drug. However, participants who have completed at least 60 days in the study can continue the treatment, the company said in a statement.

The company said "majority of the impacted patients were determined to have concurrent complications known historically to predispose to drug-induced liver injury."

Following talks with the FDA about these cases, study protocols and enrollment criteria were revised in May 2022.

Enrollment in these trials continues with the revised study protocols and enhanced safety monitoring in countries outside of the U.S, Sanofi said.

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