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  • Sanofi gets CDSCO...

Sanofi gets CDSCO panel nod to study atopic dermatitis drug Amlitelimab

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2023-09-27T18:00:17+05:30  |  Updated On 27 Sept 2023 6:00 PM IST
USFDA grants priority review to Sanofi-Regeneron Dupixent for bullous pemphigoid
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New Delhi: The drug major Sanofi has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase II clinical trial of Amlitelimab, a fully human monoclonal antibody, being developed by Sanofi for the treatment of atopic dermatitis.

However, this approval is subject to the condition that the firm should provide clear written direction/training on Amlitelimab to the principal investigator and sites that they should be liberal to the subjects who want rescue treatment and should not unnecessarily withhold it.

This came after the drug major Sanofi presented the Phase II clinical trial protocol No. LTS17789 Version 1 dated 31 Oct 2022 before the committee.

Amlitelimab provided statistically significant improvements in signs and symptoms of moderate to severe atopic dermatitis in adults whose disease could not be adequately controlled with topical medications or where topical medications are not a recommended treatment approach.

Atopic dermatitis (eczema) is a condition that causes dry, itchy, and inflamed skin. It's common in young children but can occur at any age. Atopic dermatitis is long-lasting (chronic) and tends to flare sometimes. It can be irritating but it's not contagious.

Amlitelimab was found in a pharmacokinetic study to reduce skin redness, indicating its potential as a novel pharmacological treatment in immune-mediated disorders. Earlier work revealed how amlitelimab leads to a significant reduction of interleukin-13 levels with a corresponding reduction in dermatitis disease severity. Furthermore, the drug also improves disease severity through targeting interleukin-22.

Amlitelimab is designed to rebalance the immune system by blocking inappropriate activation and proliferation of 'pro-inflammatory' effector T cells and promoting the expansion of 'anti-inflammatory' regulatory T cells, without broad suppression of the immune system.

At the recent SEC meeting for dermatology and allergy held on 13th September 2023, the expert panel reviewed the proposal presented by the drug major Sanofi for the Phase II clinical trial of the dermatology drug Amlitelimab.

After detailed deliberation, the committee recommended the grant of permission to conduct Phase II Clinical trial subject to the condition that the firm should provide clear written direction/training to the principal investigator and sites that they should be liberal to the subjects who want rescue treatment and should not unnecessarily withhold it.

Also Read:AstraZeneca gets CDSCO Panel Nod to study asthma drug Benralizumab

Amlitelimabcdscosanofiatopic dermatitis
Dr. Divya Colin
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.

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