Submit Modified Informed Consent Form with details: CDSCO Panel Tells Sanofi om Multiple Sclerosis Drug Tolebrutinib

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-01-21T18:00:52+05:30 | Updated On 22 March 2024 10:03 PM IST

Sanofi Gets CDSCO Panel Nod to Study Venglustat

New Delhi: Reviewing the Phase III clinical study protocol of Tolebrutinib presented by the drug major Sanofi, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm submit the modified Informed Consent Form mentioning the details about 11 times visit to the site.

Furthermore, the expert panel suggested the firm to submit the volume of samples to be collected and compensation to be paid in case of a visit to the site or home visit, clearance for shipping of samples outside the country, if any, and written assurance for a home visit if the patient is unable to visit the site.

This came after the drug major Sanofi presented phase III clinical study protocol no. LTS17043.

Tolebrutinib is a new drug being investigated for the treatment of relapsing, secondary, and primary progressive multiple sclerosis.

Tolebrutinib, a CNS-penetrant BTK inhibitor, has a dual mechanism of action, acting on both adaptive and innate immunity. Bruton's tyrosine kinase mediates adaptive immunity by coupling the antigenic stimulation of the B-cell receptor to nuclear signaling that leads to acute inflammatory responses.

At the recent SEC meeting for Neurology and Psychiatry held on 20th December 2023, the expert panel reviewed the Phase III clinical study of the multiple sclerosis drug Tolebrutinib.

After detailed deliberation, the committee opined that the firm should submit the following for review by the committee:

1. Modified Informed Consent Form mentioning the details about 11 times visit the site, volume of sample to be collected, and compensation to be paid in case of a visit to the site or home visit.

2 Clearance for shipping of samples outside the country, if any.

3. Written assurance for home visit if the patient is unable to visit the site.

Also Read: Dr Mansukh Mandaviya inaugurates CDSCO Sub Zonal Office, Central Drug Testing Laboratory in Indore

sanofimultiple sclerosis drugcdscotolebrutinibphase 3 trial

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751