Glaxo’s Benlysta lupus treatment approved in China for adults

GlaxoSmithKline said on Thursday that Benlysta (belimumab) has been approved in China for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard of care.

Benlysta was already approved in China as an add-on therapy in adults and children aged five years and older with active systemic lupus erythematosus (SLE). This approval makes belimumab China's first and only biologic medicine approved for SLE and LN, Glaxo said.

Dr Hal Barron, chief scientific officer and president R&D, at GSK, said: "Nearly 500,000 people in China have systemic lupus erythematosus and more than half of these patients will develop one of the most common and serious complications, lupus nephritis.

"Recognising that lupus nephritis can lead to kidney damage, this approval will allow patients in China access to a new treatment option to help slow the progressive nature of systemic lupus."

Since December 2020, belimumab has been approved for active LN by 16 regulatory bodies around the world, including the U. Food and Drug Administration, European Medicines Agency, and NMPA.

In addition, belimumab is approved in 60 countries for SLE, and approved and available for use for both SLE and LN in more than 25 countries worldwide to date.