GSK : New approval of benlysta for lupus in china
GlaxoSmithKline (GSK) reports that China's National Medical Products Administration (NMPA) has approved Benlysta (belimumab) as a treatment for adult patients with active lupus nephritis (LN). Until now, Benlysta was indicated in China for the treatment, from the age of five, of active systemic lupus erythematosus (SLE).
This approval, therefore, makes belimumab China's first and only biologic drug approved for SLE and LN.
This approval is based on data from a phase III trial which showed that over two years, belimumab combined with standard treatment increased renal response rates and helped reduce the risk of worsening kidney disease in patients. patients with active LN compared to standard therapy alone.