LONDON (dpa-AFX) - GlaxoSmithKline Plc or GSK (GSK), said on Thursday that China's National Medical Products Administration or NMPA has approved Belimumab, sold under the brand name Benlysta, for the adult patients with active lupus nephritis or LN, who are receiving standard of care.
The approval extends the current indication in China as add-on therapy in adults and children aged five years and older with active systemic lupus erythematosus (SLE). It also makes belimumab as China's first and only biologic medicine approved for SLE and LN.
Nearly 500K people in China have systemic lupus erythematosus and over half of these patients will develop one of the most common and serious complications, lupus nephritis.
The NMPA approval is based on data from the Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis (BLISS-LN) phase III trial.
Since December 2020, belimumab has been approved for active LN by 16 regulatory bodies around the world, including the US 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 over 25 countries worldwide.
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