Sanofi Gets CDSCO Panel Nod to Study COPD drug Itepekimab
New Delhi: The drug major Sanofi has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of the REGN3500 (Itepekimab) 300 mg (150 mg/mL) Solution in Chronic Obstructive Pulmonary Disease (COPD).This came after the drug maker Sanofi presented phase III clinical study protocol No....
New Delhi: The drug major Sanofi has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of the REGN3500 (Itepekimab) 300 mg (150 mg/mL) Solution in Chronic Obstructive Pulmonary Disease (COPD).
This came after the drug maker Sanofi presented phase III clinical study protocol No. LTS18133 version No. 1 dated 24 October 2023.
Itepekimab (REGN-3500) is a monoclonal antibody of IL-33. Itepekimab reduces airway inflammation and related tissue damage in previous clinical studies. Itepekimab has potential applications in asthma, chronic obstructive pulmonary disease (COPD), and atopic dermatitis (AD).
Itepekimab is under development for the treatment of chronic obstructive pulmonary disease. It is administered intravenously and subcutaneously. The drug candidate is a fully human monoclonal antibody that acts by targeting the interleukin-33 (IL-33).
At the recent SEC meeting for Pulmonary held on 6th February 2024, the expert panel reviewed the Phase III clinical study protocol No LTS18133 version No. 1 dated 24 October 2023 presented by the drug major Sanofi.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.
Also Read: CDSCO releases regulatory guidelines for sampling of drugs, cosmetics and medical device
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd