Glax­o­SmithK­line's Benlysta earns first FDA ap­proval for lu­pus nephri­tis as com­peti­tors wait in the wings

When Glax­o­SmithK­line earned its first ap­provals back in 2011 for Benlysta, it promised reg­u­la­tors it would keep the ball rolling in its pur­suit of lu­pus nephri­tis, a se­vere form of the au­toim­mune dis­ease that can cause re­nal fail­ure. Now, near­ly a decade af­ter the bi­o­log­ic first hit the mar­ket, GSK has made good on that promise.

The FDA on Thurs­day ap­proved in­tra­venous and sub­cu­ta­neous Benlysta to treat LN, mak­ing it the first ther­a­py ever ap­proved for that in­di­ca­tion.

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