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Submit preliminary analysis of primary data of subjects above 18 years in India: CDSCO Panel Tells Sanofi on Amlitelimab study

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-05-19T18:00:15+05:30  |  Updated On 19 May 2024 6:00 PM IST
CDSCO Panel Approves Fabrazyme Label Update, Asks Sanofi to Submit EMA Nod
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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.

Also Read: SII makes strategic investment in IntegriMedical, India's First Needle-Free Injection System Technology

sanoficdscoatopic dermatitis (AD)atopic dermatitiseczemaphase 3 trialAmlitelimab
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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