GSK’s Benlysta becomes first FDA-approved IV therapy for paediatric lupus

pharmafile | April 30, 2019 | News story | Manufacturing and Production, Sales and Marketing Benlysta, FDA, GSK, Lupus, US, pharma 

GSK has scored approval in the US with Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE) in paediatric patients over the age of five, it has emerged.

The FDA has awarded marketing authorisation following priority review for the intravenous formulation of the B-lymphocyte stimulator (BLyS)-specific inhibitor in the treatment of active, autoantibody-positive, SLE in children who are receiving standard therapy. The latest decision expands the existing authorised use of the IV formulation in adult patients.

The decision was based on data which showed that 52% of trial participants treated with Benlysta plus standard therapy achieved a clinically meaningful improvement in disease activity compared to 43.6% with placebo plus standard therapy.

GSK also noted that this approval marks the first authorisation of the IV form of the drug in the treatment of patients, as it is not approved in this indication anywhere else in the world, though regulatory reviews are ongoing.

“Lupus is a potential life-threatening disease that can be more aggressive and severe in children than it is in adults,” remarked Stevan W Gibson, President and CEO of the Lupus Foundation of America. “For the first time, children with lupus will now have a lupus-specific treatment option for their disease. As a research community we all share in the excitement of this historic milestone as it underscores our dedication to bringing new treatments to people living with lupus.”

Matt Fellows

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