- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
CDSCO panel approves Sanofi Healthcare's protocol amendment proposal to study SAR441566
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.
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-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