Sanofi gets CDSCO Panel nod to study Amlitelimab
New Delhi: The drug major Sanofi has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a phase III clinical study of Amlitelimab.
However, this approval is subject to the requirement that the firm submit a separate detailed protocol and procedure to ensure standardized monitoring across all the study sites, specifically a detailed document informing investigators about screening for cutaneous/extracutaneous lymphoma steps of diagnosis and reporting to CDSCO.
This came after Sanofi presented Phase III clinical study protocol No. EFC17600 version no. 1 dated 01.02.24.
Amlitelimab is a fully human, non-depleting, anti-OX40L monoclonal antibody that binds to OX40L on APCs, preventing interaction with OX40 on activated T cells.
The mechanism of action for Amlitelimab is centered around its ability to inhibit the interaction between the OX40 receptor and its ligand, OX40L. The OX40 receptor is expressed on the surface of activated T cells, a type of immune cell that plays a crucial role in the body's immune response. Amlitelimab inhibits OX40-OX40L interaction and can be used in the research of atopic dermatitis.
At the recent SEC meeting for dermatology and allergy held on 8th October 2024, the expert panel reviewed the Phase III clinical study protocol No. EFC17600 version no. 1 dated 01.02.24.
After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial with the condition that the firm should submit to CDSCO a separate detailed protocol and procedure to ensure standardized monitoring across all the study sites, specifically a detailed document informing investigators about screening for cutaneous/extracutaneous lymphoma steps of diagnosis and reporting.
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