Sanofi Healthcare Gets CDSCO Panel Nod To Study Amlitelimab for atopic dermatitis
New Delhi: Drug major Sanofi Healthcare India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of amlitelimab in adult participants with moderate to severe atopic dermatitis.
This came after Sanofi Healthcare India presented phase II/III clinical study protocol no. LTS17367 amendment number 05 version 1 Dated 16 Aug 2024.This is a long-term extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous amlitelimab in adult participants with moderate to severe atopic dermatitis.
Amlitelimab (SAR445229) is a fully human, non-cytotoxic, non-depleting anti-OX40L immunoglobulin (Ig)G4 monoclonal antibody.
Atopic dermatitis (AD) is an inflammatory skin disease with significant unmet need. 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 is a novel way to modulate persistent inflammation.
Amlitelimab is a new drug being studied that targets an important molecule in the immune system called OX40 ligand (OX40L). Blocking OX40L may stop or ease symptoms of AD.
At the recent SEC meeting for dermatology and allergy held on January 16, 2025, the expert panel reviewed the phase II/III clinical study protocol no. LTS17367 amendment number 05 version 1 Dated 16 Aug 2024.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.
