GSK’s Benlysta Approved in Europe for Adults with Active Lupus Nephritis
GlaxoSmithKline (GSK)’s Benlysta (belimumab), in combination with immunosuppressants, has won approval in the EU for treating adults with active lupus nephritis.
The European Commission’s decision expands the drug’s prior indication for treating systemic lupus erythematosus. GSK recently received a similar expanded approval for Benlysta in the U.S.
The marketing authorization was supported by phase 3 study results from a 448-participant trial, which demonstrated that Benlysta plus standard therapy improved kidney response rates and prevented worsening of kidney functions vs. standard therapy alone.
“Benlysta is the first biologic approved to treat lupus and lupus nephritis … for patients and physicians across Europe dealing with this complex autoimmune disease,” said Hal Barron, GSK’s chief scientific officer and president of research and development.