Sanofi: FDA places clinical hold on tolebrutinib trials

(CercleFinance.com) - Sanofi said on Thursday that the US Food and Drug Administration had placed a clinical hold on patient enrollment in ongoing late-stage trials of its treatment of multiple sclerosis and myasthenia gravis.


The French company said the FDA's action follows a limited number of cases of drug-induced liver injury that have been identified with tolebrutinib in the phase 3 studies.

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

The Paris-listed shares were down 3 percent on the news.

Copyright (c) 2022 CercleFinance.com. All rights reserved.