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 2024-05-19 12:30 GMT   |   Update On 2024-05-19 12:30 GMT
Advertisement

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.

Advertisement

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

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News