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Chinese regulators approve GSK’s Benlysta for lupus nephritis

By Brian Buntz | February 10, 2022

GSKGlaxoSmithKline plc (LSE/NYSE:GSK) has announced that China’s National Medical Products Administration (NMPA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN), a type of kidney disease affecting more than half of those with systemic lupus erythematosus (SLE).

Benlysta is the only biologic approved to treat SLE and lupus nephritis in China.

The recent indication is constrained to patients receiving standard of care for LN.

The indication for SLE, the most common form of lupus, covers adults and children at least five years old.

FDA approved Benlysta as a lupus treatment in 2011. Approval extended to children at least five years old in 2019. In December 2020, FDA approved an indication of the drug for adults with lupus nephritis.

NMPA approved the new indication after reviewing data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) Phase study.

At present, the standard of care for LN involves a combination of steroids and the use of mycophenolate mofetil (MMF) or cyclophosphamide (CYC).

 


Filed Under: Rheumatology
Tagged With: belimumab, Benlysta, GlaxoSmithKline plc, GSK, LN, lupus nephritis, SLE, systemic lupus erythematosus
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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