Submit preliminary analysis of primary data of subjects above 18 years in India: CDSCO Panel Tells Sanofi on Amlitelimab study
New Delhi: After considering the phase III clinical study protocol of the monoclonal antibody Amlitelimab in the treatment of moderate-to-severe Atopic Dermatitis, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Sanofi to submit the preliminary analysis of primary data of subjects above 18 years in India.
This came after the drug major Sanofi presented Phase III clinical study protocol No. EFC17600 version No. 01 dated 01.02.2024.
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. People with atopic dermatitis are at risk of developing food allergies, hay fever, and asthma. Moisturizing regularly and following other skin care habits can relieve itching and prevent new outbreaks (flares). It is an inflammatory skin disease with significant unmet needs.
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