2022-07-29| Trials & Approvals

GSK’s Benlysta Bags US Approval for Lupus Complication

by Joy Lin
Share To

GlaxoSmithKline has announced the US FDA approval of Benlysta (belimumab) for the treatment of active lupus nephritis (LN) in children aged 5 to 17 who are on active therapy. 

The approval makes Benlysta the first approved treatment for pediatric LN, building on its 2020 approval for adult LN. Benlysta was originally approved in 2011 for systemic lupus erythematosus (SLE), or lupus.

Related article: EMA Begins Reviewing Cancer Medicine for COVID-19 Without Manufacturer’s Application

Treatment for a Serious Complication 

Lupus is an autoimmune disease where the immune system attacks multiple tissues and organs. Lupus nephritis occurs when lupus autoantibodies affect the kidney, causing inflammation that may lead to impaired kidney function or even kidney failure. 

Most cases of pediatric LN occur within the first two years of their initial diagnosis, said Stevan W. Gibson, President and CEO of Lupus Foundation of America. 

Treatment options for children with LN were mainly limited to non-selective immunosuppressants and corticosteroids. 

Benlysta is a human monoclonal antibody that targets and inhibits B lymphocyte stimulator (BLyS), an important cytokine factor in the survival and apoptosis of B cells. This reduces the differentiation of B cells into autoantibody-producing plasma cells, subsequently lessening autoantibody attack on the kidney. 

“The long-term goal of lupus nephritis management in adults and children is to preserve renal function while minimizing treatment-related toxicities and associated morbidity,” said Herson Quinones, VP, Specialty and Pipeline US Medical Affairs, GSK. “This Benlysta approval highlights GSK’s commitment to bring treatment options to children living with lupus nephritis.

Benlysta brought in £297 million in the second quarter of 2022, growing by double digits due to strong US demand.


© All rights reserved. Collaborate with us:
Related Post
Retail Pharmacies Can Dispense Abortion Pills Under New FDA Ruling
The FDA and Biogen Taking Heat for Aduhelm’s Approval Process
GeneOnline’s Pick: Top 10 M&A Deals in 2022
Junshi’s PD-1 Antibody Meets Endpoint In Phase 3 Lung Cancer Trial
Moderna Welcomes Phase 3 Win For RSV Vaccine
Moving Beyond COVID With mRNA Technology
Rob Knight and Jing-Yuan Fu Elaborate On Microbiome Research Trends at the 7th Asia Microbiome Conference(AMC)
CARsgen Taps Huadong to Commercialize Multiple Myeloma CAR-T in China
Scientists Study Imaging Probes in First-Ever Amputated Human Limb Model
EMA Plans to Issue Liver Failure Warning for Novartis’ Gene Therapy
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!