GlaxoSmithKline 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).