Sanofi’s Tolebrutinib Phase 3 Clinical Trial Paused Globally After FDA Clinical Hold

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

https://www.fdanews.com/

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