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Sanofi Pauses Patient Enrollment in P-III Studies of Tolebrutinib for the Treatment of Multiple Sclerosis and Myasthenia Gravis in the US

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Sanofi Pauses Patient Enrollment in P-III Studies of Tolebrutinib for the Treatment of Multiple Sclerosis and Myasthenia Gravis in the US

Sanofi Pauses Patient Enrollment in P-III Studies of Tolebrutinib for the Treatment of Multiple Sclerosis and Myasthenia Gravis in the US

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

Ref: Sanofi | Image: Sanofi

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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