GSK's Belimumab Receives NMPA Approval as First Innovative Therapy for Pediatric Systemic Lupus Erythematosus in China

Today, information on the official website of China’s National Medical Products Administration (NMPA) shows that the application status for the marketing authorization of GlaxoSmithKline’s (GSK) injectable belimumab has been updated to “Approval Completed – Pending Certificate Issuance,” with the drug approval number S20190033. This indicates that the new indication for this drug has been approved in China. According to earlier public announcements by the Center for Drug Evaluation (CDE), the newly approved indication is: in combination with standard therapy, for patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who remain highly disease-active despite standard therapy (e.g., positive anti-dsDNA antibodies and hypocomplementemia, SELENA-SLEDAI score ≥8).

Publicly available information indicates that belimumab is the first biologic agent approved globally for the treatment of systemic lupus erythematosus (SLE). Its recent approval for a new indication in China also means it has become the first innovative therapy approved by both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) for treating pediatric patients with lupus.

Screenshot Source: Screenshot from NMPA Official Website Query

Belimumab is a humanized monoclonal antibody that specifically binds to BLyS (B-lymphocyte stimulator), inhibiting B-cell survival. Mechanistically, this drug effectively suppresses autoreactive B cells and impedes their differentiation into plasma cells that produce immunoglobulins. Previously, the product was approved by the FDA in 2011 and 2019 for the treatment of adult and pediatric patients with systemic lupus erythematosus (SLE), respectively.

In China, belimumab was approved for marketing in July 2019 through priority review, indicated for adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who remain highly disease-active despite conventional therapy. In April this year, the new indication application for this product was included in the priority review by the Center for Drug Evaluation (CDE) as a pediatric medication.

Source: CDE Official Website

Among these, the potential of belimumab in treating pediatric SLE patients has been validated in clinical trials. In one study, 93 pediatric patients with SLE received intravenous infusions of belimumab for up to 52 weeks. The results showed that a higher proportion of patients receiving belimumab combined with standard therapy achieved the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) compared to those receiving placebo plus standard therapy. Meanwhile, children in the treatment group had a lower risk of severe flares and longer intervals between flares.

Research has confirmed the potential of belimumab in addressing the unmet medical needs of pediatric patients with systemic lupus erythematosus (SLE). Based on efficacy data, this indication was granted Priority Review by the U.S. Food and Drug Administration (FDA) and received accelerated approval. The recent approval of this indication in China also benefited from the Priority Review pathway offered by the Center for Drug Evaluation (CDE), a fast-track review and approval process. This accelerated approval provides a new treatment option for pediatric SLE patients in China, helping them better manage this refractory and life-impacting autoimmune disease.

Lupus erythematosus is a connective tissue disease mediated by autoimmunity, characterized prominently by immune-mediated inflammation, and classified as a dermatological condition. Systemic lupus erythematosus (SLE) is the most common type of lupus, accounting for approximately 70% of all lupus cases. It is a chronic autoimmune disease that affects multiple systems and organs and is associated with the presence of various autoantibodies. Currently, there is no complete cure for this condition.

Compared with adult patients, pediatric patients are more susceptible to renal and central nervous system involvement, and their disease progression is typically more aggressive. These children often require lifelong treatment, and the cumulative side effects associated with long-term therapy are significant. Therefore, there is an urgent clinical need for innovative therapies to improve outcomes in this patient population.

References:

[1] Administrative Service Center of the China National Medical Products Administration. Retrieved Dec 7, 2019, 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 approves first treatment for pediatric patients with lupus, Retrieved April 26, 2019, from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636756.htm

[3] Benlysta, the world’s first biologic agent for the treatment of systemic lupus erythematosus, approved for marketing in mainland China. Retrieved July 16, 2019, from https://www.prnasia.com/story/252045-1.shtml

[4] Official Website of the Center for Drug Evaluation, National Medical Products Administration. Retrieved April 14, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=25

Source: Pharma Horizon

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