CDSCO panel approves Sanofi Healthcare's protocol amendment proposal to study SAR441566

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-11-01 12:00 GMT | Update On 2024-11-01 12:00 GMT

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Sanofi Healthcare India for the protocol amendment of the study titled, 'A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (SPECIFI-RA)'

Furthermore, regarding the study, the expert panel has approved the firm to increase the number of subjects from 10 to 24 in India as presented by the firm.

This came after the firm presented protocol amendment 3 version 01 dated 03 July 2024 protocol no. DRI17821 and an increase in number of subjects from 10 to 24.

SAR-441566 is under development for the treatment of inflammatory bowel disease, rheumatoid arthritis and plaque psoriasis. It is administered through the oral route. The drug candidate acts by targeting TNF.

The molecule SAR441566 stabilizes an asymmetrical form of the soluble TNF trimer, compromises downstream signaling, and inhibits the functions of TNF in vitro and in vivo

At the recent SEC meeting for analgesics and rheumatology held on 3rd October 2024, the expert panel reviewed the protocol amendment 3 version 01 dated 03 July 2024 protocol no. DRI17821.

After detailed deliberation, the committee recommended the approval of the protocol amendment and an increase in the number of subjects from 10 to 24 in India as presented by the firm.

Also Read: Exemed Pharmaceuticals gets CDSCO Panel nod to study Sacubitril plus Valsartan film-coated sustained release tablet

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Dr. Divya Colin

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.

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CDSCO panel approves Sanofi Healthcare's protocol amendment proposal to study SAR441566

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