GSK’s Mepolizumab Nears Approval in China for EGPA Treatment

By | Pharma Observer

Public disclosures from China's National Medical Products Administration (NMPA) indicate that the marketing approval application status for GlaxoSmithKline (GSK)'s anti-IL-5 monoclonal antibody mepolizumab injection has been updated to "under review," suggesting that the drug is expected to be approved in China in the near future. Public information shows that this application for mepolizumab is for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Screenshot source: NMPA official website

Mepolizumab is a "first-in-class" anti-IL-5 humanized monoclonal antibody that selectively recognizes and binds to IL-5, blocking the binding of IL-5 to its receptors on the surface of eosinophils, reducing eosinophil proliferation, and showing promise in alleviating various diseases caused by eosinophilia.

In the United States, the FDA has approved mepolizumab for multiple indications, including severe asthma, adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES), and patients with chronic rhinosinusitis with nasal polyps (CRSwNP), among others. Notably, mepolizumab is also the first globally approved anti-IL-5 monoclonal antibody.

In China, the marketing authorization application for mepolizumab was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2020 and granted priority review status, with proposed development for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Based on the clinical trial data supporting the US approval of mepolizumab for this indication, compared with placebo, the time to remission was significantly prolonged in patients receiving mepolizumab. At Week 36 and Week 48 of treatment, the proportion of patients achieving remission in the mepolizumab group was significantly higher than that in the placebo group. Compared with the placebo group, the proportion of patients treated with mepolizumab who achieved remission by Week 24 was significantly increased, and remission was sustained throughout the 52-week treatment study period.

Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare autoimmune disease. Its clinical manifestations include asthma, elevated eosinophil levels, and inflammation of small- and medium-sized blood vessels. Inflamed vessels can affect various organ systems, including the lungs, gastrointestinal tract, skin, heart, and nervous system, severely impacting patients' quality of life. We look forward to the early approval of mepolizumab in China, bringing new treatment options to patients.

References:

[1] National Medical Products Administration of China. Drug Registration Progress Inquiry. Retrieved Sep 15, 2021, from http://sq.nmpa.gov.cn/datasearch_nmpa/schedule/search.jsp?tableId=43&tableName=TABLE43&columnName=COLUMN464,COLUMN475&title=%D2%A9%C6%B7%D7%A2%B2%E1%BD%F8%B6%C8%B2%E9%D1%AF

[2]FDA Today Approves First New Drug for Rare Vasculitis. Retrieved Dec 13, 2017, from https://mp.weixin.qq.com/s?__biz=MzAwMDA5NTIxNQ==&mid=2649968375&idx=6&sn=61700633b5e3a28fb506751594e8a889&chksm=82e9c877b59e4161a20cd27505ed2b4b81f91fce79e42b1b880c052cc3357d15aa6300998e44#rd

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