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.
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