GSK Belimumab Approved in China for Systemic Lupus and Active Lupus Nephritis in Adults

TextPharmaceutical Guanlan

On February 9, the official website of China's National Medical Products Administration (NMPA) announced that the new indication marketing application of GlaxoSmithKline (GSK)'s belimumab for injection has been approved
.

According to GSK's public information, belimumab is the first drug approved for the treatment of systemic lupus and adults with active lupus nephritis

Screenshot source: NMPA official website

Belimumab (English trade name: Benlysta) is a humanized monoclonal antibody that specifically binds to BLyS (B lymphocyte stimulating factor) to inhibit the survival of B cells
.

Mechanistically, this drug can effectively inhibit self-reactive B cells and make it difficult for B cells to differentiate into plasma cells that produce immunoglobulins

In China, belimumab was approved for marketing through priority review in July 2019, and is suitable for active, autoantibody-positive adult patients with systemic lupus erythematosus who still have high disease activity on the basis of conventional treatment
.

In December 2020, the product was approved again for a new indication in China for patients with systemic lupus erythematosus aged 5 years and above

It is worth mentioning that belimumab is also the first FDA-approved therapy for lupus nephritis
.

It was approved in the U.

FDA approval is based on positive results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial
.

Results of the study showed that among adults with active lupus nephritis, belimumab + standard of care (43%) achieved major outcomes after the second year of treatment compared with placebo + standard of care (32%).

In lupus nephritis, the immune system attacks the kidneys, causing inflammation of the small blood vessels that filter waste from the kidneys, and patients experience 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

About 40 percent of people with systemic lupus erythematosus develop lupus nephritis, which causes inflammation of the kidneys and can lead to end-stage renal disease, GSK said in a press release
.

Belimumab is the first drug approved for the treatment of systemic lupus and adults with active lupus nephritis, an important therapeutic advance for patients with this incurable autoimmune disease

References:

[1] On February 09, 2022, the information on the pending drug approval documents was released.