By Joe Hoppe


GlaxoSmithKline PLC said Thursday that China's National Medical Products Administration has approved its Benlysta product, for treatment of adult patients with active lupus nephritis who are receiving standard of care.

The pharmaceutical giant said that the approval extends the current indication in China for the drug to be used as an add-on therapy in adults and children of five-years and older with active systemic lupus erythematosus, an autoimmune disease.

The approval makes Benlysta the first and only biologic approved in China for both systemic lupus erythematosus, and lupus nephritis, caused by SLE. The product can help preserve kidneys and allow for a reduction in doses of steroids and immunosuppressants that would otherwise be used, which can have toxic side effects.

Nearly half a million people in China have SLE, and more than half of these will develop lupus nephritis.

"Recognizing 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," Chief Scientific Officer and Research and Development President Hal Barron said.

Shares at 0911 GMT were up 8.6 pence, or 0.5% at 1,629.0 pence.


Write to Joe Hoppe at joseph.hoppe@wsj.com


(END) Dow Jones Newswires

02-10-22 0430ET