Sanofi Pauses Patient Enrollment in P-III Studies of Tolebrutinib for the Treatment of Multiple Sclerosis and Myasthenia Gravis in the US
- The US FDA temporarily paused patient enrolment in the P-III studies of tolebrutinib in MS & MG. Participants who have been enrolled in the study for ≤60 days in the US must stop taking the treatment while those who have completed 60 days maintain their treatment
- The decision was based on a limited no. of cases of drug-induced liver injury linked to tolebrutinib exposure in P-III studies while affected individuals had concurrent problems that were known to historically predispose them to drug-induced liver impairment
- The trial program's enrollment continues with updated research protocols & improved safety monitoring outside of the US. To assess the efficiency & safety measures, the company collaborates with researchers globally & IDMC's members
Ref: Sanofi | Image: Sanofi
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