GSK's Belimumab Receives NMPA Approval in China for Systemic Lupus Erythematosus and Adult Active Lupus Nephritis

ByMedView

On February 9, the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that the new indication application for GlaxoSmithKline’s (GSK) injectable drug belimumab has been approved. According to publicly available information from GSK, belimumab is the first drug approved for the treatment of systemic lupus erythematosus and active lupus nephritis in adults.

Screenshot source: NMPA official website

Belimumab (English trade name: Benlysta) is a humanized monoclonal antibody that specifically binds to BLyS (B lymphocyte stimulator) and inhibits the survival of B cells. Mechanistically, this drug effectively suppresses autoreactive B cells and makes it less likely for B cells to differentiate into plasma cells that produce immunoglobulins. Previously, this product has been successively approved by the FDA for adult and pediatric patients with systemic lupus erythematosus, as well as adult patients with active lupus nephritis.

In China, belimumab was approved for marketing through priority review in July 2019. It is suitable for adult patients with active, autoantibody-positive systemic lupus erythematosus who still have high disease activity based on conventional treatment. In December 2020, the product was again approved in China for a new indication, for use in patients with systemic lupus erythematosus aged 5 years and above. Belimumab has thus become the first innovative therapy approved by the US FDA and China NMPA that can treat pediatric lupus patients.

Notably, belimumab is also the first FDA-approved therapy for lupus nephritis. It was approved in the United States in December 2020 for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.

FDA Approval Based on Positive Results of a Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Trial. The study results showed that, in adult patients with active lupus nephritis, the proportion of patients achieving Primary Efficacy Renal Response (PERR) after 2 years of treatment was significantly higher in the belimumab plus standard therapy group (43%) compared to the placebo plus standard therapy group (32%). All four major secondary endpoints reached statistical significance compared to placebo, including complete renal response and time to renal-related events or death.

In lupus nephritis, the immune system attacks the kidneys, causing inflammation in the small blood vessels that filter waste in the kidneys, leading to symptoms such as proteinuria, elevated serum creatinine, and urinary sediment. Despite improvements in diagnosis and treatment over the past few decades, lupus nephritis remains an indicator of poor prognosis.

GSK once stated in a press release that about 40% of patients with systemic lupus erythematosus develop lupus nephritis, which causes inflammation in the kidneys and can lead to end-stage renal disease. Belimumab is the first drug approved to treat systemic lupus and active lupus nephritis in adults, representing a significant therapeutic advancement for patients with this currently incurable autoimmune disease.

References:

[1] Information on Pending Drug Approval Documents Released on February 9, 2022. Retrieved Feb 9, 2022, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20220209100101132.html

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

[3] FDA approves GSK's BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US. Retrieved December 17, 2020, from https://www.prnewswire.com/news-releases/fda-approves-gsks-benlysta-as-the-first-medicine-for-adult-patients-with-active-lupus-nephritis-in-the-us-301195182.html

▽Follow 【WuXi AppTecGermany】WeChat Official Account