GSK gets EMA panel recommendation to approve Benlysta for adult patients with active lupus nephritis
UK: GlaxoSmithKline plc (GSK) has recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the use of intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN).
The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. If approved, Benlysta would become the first and only biologic approved for both Systemic Lupus Erythematosus (SLE) and LN in the European Union. This CHMP opinion follows the recent label expansion by the US Food and Drug Administration to include LN.
Christopher Corsico, Senior Vice President, Development, GSK, said: "Active lupus nephritis occurs in more than 1 million patients with systemic lupus erythematosus worldwide. It causes inflammation in the kidneys and can lead to end-stage kidney disease which may require dialysis or a transplant. The CHMP's positive opinion brings us one step closer to providing physicians and patients in Europe with the first treatment option specifically designed to work in lupus and lupus nephritis."
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