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
