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Submit details of adverse events reported: CDSCO Panel Tells GSK on Mepolizumab Powder for Solution for Injection

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-08-24T18:00:56+05:30  |  Updated On 24 Aug 2024 6:00 PM IST
GSK in breach for misleading prescription information on Omjjara: industry body
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New Delhi: In line with the Phase IV clinical trial report of the monoclonal antibody Mepolizumab (Brand Name: Nucala 100 mg) presented by the drug major GlaxoSmithKline Pharmaceuticals, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to submit the detailed elaboration of adverse events reported in the study.

This came after the drug maker GlaxoSmithKline Pharmaceuticals presented the results of a Phase-4 clinical study titled 'A Phase 4, open-label, single arm, 24-week, phase 4 study to evaluate the safety and efficacy of Mepolizumab 100 mg SC administered every 4 weeks in Indian Participants ages > 12 years with severe eosinophilic asthma requires oral corticosteroid treatment to maintain asthma control (PRISM)' vide Protocol No. 209682 amendment No. 4 dated 23.08.2022.

Mepolizumab is a fully-humanized monoclonal IgG1 kappa anti-IL-5 antibody used in conjunction with other therapies to treat severe asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.

Mepolizumab was first approved by the FDA on November 4, 2015, as an add-on therapy for severe asthma and marketed under the brand name Nucala by GlaxoSmithKline.

Mepolizumab binds to IL-5, blocking its binding to the alpha chain of the IL-5 receptor complex. This inhibits IL-5 signaling, reducing the production and survival of eosinophils. It may cause hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, and rash).

At the recent SEC meeting for pulmonary held on August 6, 2024, the expert panel reviewed the results of a Phase-4 clinical study to evaluate the safety and efficacy of Mepolizumab 100 mg SC administered every 4 weeks in Indian participants ages > 12 years with severe eosinophilic asthma who require oral corticosteroid treatment to maintain asthma control (PRISM).

After detailed deliberation, the committee recommended the firm submit the detailed elaboration of AE’s (adverse events) reported in the study for further evaluation by the committee.

Also Read: Bristol Myers Squibb India Gets CDSCO Panel Nod to Study anticancer drug Mezigdomide

gskglaxosmithklinemepolizumabeosinophilic asthmaadverse eventsnucala
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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