Last Updated on January 4, 2024 by The Health Master
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to pharmaceutical major Sanofi to conduct the study of Dupilumab used to treat the symptoms of Atopic Dermatitis.
This came after the firm presented their Phase II/III Clinical trial protocol no: EFC16723, amendment 01 (Version 1) dated July 8, 2021.
Dupilumab is a human monoclonal antibody of the immunoglobulin G4 subclass that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4 receptor alpha subunit.
It is used to treat moderate to severe atopic dermatitis, asthma, and nasal polyps accompanied by chronic rhinosinusitis in adolescents and adults.
Dupilumab is an interleukin-4 (IL-4) receptor alpha antagonist.
As an interleukin-4 receptor alpha antagonist, dupilumab inhibits the signaling of pro-inflammatory cytokines, called interleukins (IL), that induce inflammatory and immunological reactions in several atopic or allergic conditions, such as eczema, allergic reactions, and rhinosinusitis.
Dupilumab is indicated for the treatment of patients aged six months and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Atopic dermatitis is a chronic inflammatory condition of the skin characterized by pruritus and skin changes.
Earlier, the Medical Dialogues Team had reported that the committee recommended the grant of permission to conduct the study under certain conditions.
Firstly, the committee advised that the study should be carried out in India. Furthermore, the expert panel stated that the firm should perform the QuantiFERON-TB Gold test during the screening visit to exclude latent- TB subjects from the study.
In addition, the committee advised that women of childbearing potential should be excluded from the study and that the firm should conduct pregnancy tests during the screening of women of childbearing potential in the trial.
At the recent SEC meeting for Dermatology & Allergy held on 12.07.2022, the expert panel reviewed protocol no: EFC16723, amendment 01 (Version 1) dated July 8, 2021, before the committee.
After detailed deliberation, the committee recommended the grant of permission to conduct the study with the following conditions:
1. The applicant should conduct the first part A of the study and submit its data for further review by the committee for further continuation of the trial (Part B).
2. In the event of treatment failure, the applicant should pay all expenses, including the cost of nasal surgery, to the trial subjects.
3. A Gold Quantiferon TB test should be done at the screening visit and end of treatment visit.
4. In the informed consent document, all serious adverse events (SAEs) and adverse events (AEs) of test drugs should be elaborated.
CDSCO releases draft guidance documents on IVD Medical Devices
Quality certificates of Medical Devices by other entities not a replacement for license: CDSCO
Medical device alert: CDSCO issues alert on batches of peripheral stent from US-based Cordis
Medical Device Alert: CDSCO issues alert on these Medical Devices
Side effects of painkillers: Matter sent to CDSCO
CDSCO classifies 214 Medical Devices under Medical Devices Rule, 2017
Pharma Industry seeks clarity over these mandatory digital labeling
USFDA gives nod to market this generic Antifungal medication
Health alert: India issues guidelines to tackle Monkeypox
USFDA approves this drug for weight management in aged 12 years and older
Drug recall: Propofol Injectable Emulsion recalled due to this reason
Pharma Industry urges Govt to reduce prices of IP 2022
CDSCO releases draft guidance documents on IVD Medical Devices
Highlights: Drugs, Medical Devices and Cosmetics Bill 2022
Drug alert: 26 out of 1096 samples declared as NSQ in June 2022
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
