Sanofi gets CDSCO Panel okay to study Dupilumab
New Delhi: Directing to include all Serious Adverse Events (SAEs) and adverse events (AEs) of test drug in the informed consent document, the Subject Expert Committee (SEC) functional under 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 08 July 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 reaction, 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 the committee recommended the grant of permission to conduct the study with 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 the firm should conduct pregnancy test during screening of women of child bearing potential in the trail.
At the recent SEC meeting for Dermatology & Allergy held on 12.07.2022,the expert panel reviewed the protocol no:EFC16723,amendment 01 (Version 1) dated 08 July 2021 before the committee.
After detailed deliberation, the committee recommended for grant of permission to conduct the study with following conditions:
1. The applicant should conduct first partA of the study and submit its data for further review by the committee for further continuation of the trial (Part B).
2. In case of treatment failure, the applicant should pay all expenses including cost of nasal surgery to the trial subjects.
3. Gold Quantiferon TB test should be done at screening visit & end of treatment visit.
4. In informed consent document, all Serious Adverse Events (SAEs) and adverse events (AEs) of test drug should be elaborated.
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