Shots:

• 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

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