CDSCO Panel Approves Sanofi's Protocol Amendment to study Tolebrutinib
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved Sanofi's proposal for protocol amendment of the clinical trial of Tolebrutinib.
This came after the firm presented protocol amendment 14, version 01, dated 31-Oct-2024, protocol no. EFC16035. This is a phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS).
SAR442168 (tolebrutinib) is an orally bioavailable, brain-penetrant, selective, small-molecule inhibitor of Bruton's tyrosine kinase (BTK), with potential immunomodulatory and anti-inflammatory activities.
Tolebrutinib blocks the actions of the enzyme, and it is thought that this will prevent the multiple sclerosis (MS) activity that leads to relapses as well as the longer-term damage to nerve cells, which causes progression.
At the SEC meeting for Neurology and Psychiatry held on 28th February 2025, the expert panel reviewed protocol amendment 14, version 01 dated 31-Oct-2024 protocol no. EFC16035.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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