10th Feb 2022 10:06
(Alliance News) - GlaxoSmithKline PLC said on Thursday its lupus treatment was given further approval in China.
Brentford, England-based GSK said Benlysta, or generically belimumab, an intravenous or subcutaneous biologic treatment for both lupus nephritis and active systemic lupus erythematosus, is the first of its kind to be approved in China for these kinds of lupus.
China's National Medical Products Administration has approved the treatment for adult patients with active lupus nephritis who are receiving standard of care. This is an extension of its current approved use as an add-on therapy in adults and children aged 5 and above with active system lupus erythematosus (the most common form).
The approval is based on data from a phase three trial which showed, when added to standard of care, belimumab increased renal response rates and reduced the risk of worsening kidney disease in patients with active lupus nephritis. Approximately 20% of patients with this kind of lupus progress to end-stage kidney disease in the 10 years following diagnosis.
GSK Chief Scientific Officer & President of Research & Development Hal Barron 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."
Shares in GSK were up 0.8% to 1,633.60 pence each in London on Thursday morning.
By Elizabeth Winter; [email protected]
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