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.

Amlitelimab is a fully human non-T cell depleting monoclonal antibody that blocks OX40-Ligand, a key immune regulator, and has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis.

Amlitelimab's mechanism focusing on OX40-Ligand is tailored to recalibrate the balance between the body's pro-inflammatory and regulatory T cells.

Blockade of the OX40-OX40 ligand (OX40L) costimulation pathway by targeting OX40L on antigen-presenting cells (APCs) with a fully human noncytotoxic, nondepleting anti-OX40L monoclonal antibody (amlitelimab) is a novel way to modulate persistent inflammation.

At the recent SEC meeting for dermatology and allergy held on 14th May 2024, the expert panel reviewed the Phase III clinical study protocol No. EFC17600 version No. 01 dated 01.02.2024.

After detailed deliberation, the committee opined that the firm should submit a preliminary analysis of primary data of subjects above 18 years in India for further review by the committee.

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