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Japan Approves GSK's Nucala For Treating Adults With Chronic Rhinosinusitis With Nasal Polyps

(RTTNews) - GSK plc (GSK, GSK.L) said that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for the treatment of chronic rhinosinusitis with nasal polyps or CRSwNP in adult patients, limited to those who are inadequately controlled with standard treatment.

The approval was based on results of the phase III MERIT trial, which studied the efficacy and safety of mepolizumab over a 52-week period in a population of Japanese, Chinese and Russian patients with inadequately controlled CRSwNP, supported by data from the global phase III SYNAPSE study, which explored the effect of mepolizumab vs. Placebo in more than 400 patients with CRSwNP.

Mepolizumab is approved in Japan as a treatment for bronchial asthma in children aged 6 years or older and in adults with refractory asthma whose symptoms are inadequately controlled with standard treatment, and also for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) inadequately responding to the standard treatment.

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Submit Details Of Adverse Events Reported: CDSCO Panel Tells GSK On Mepolizumab Powder For Solution For Injection

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.

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