GSK GSK plc

   By Stephen Nakrosis 
 

The U.S. Food and Drug Administration on Friday said it approved GlaxoSmithKline PLC's (GSK) Benlysta, or belimumab, intravenous infusion to treat children with systemic lupus erythematosus, commonly known as lupus.

This is the first time the administration approved a treatment for pediatric patients with lupus, it said. Benlysta has been approved for use in adult patients since 2011.

The FDA said childhood-onset SLE is rare, but is generally more active in children and adolescents than adult patients. As a result of the disease starting early in life, pediatric patients have a higher risk for developing increased organ damage and complications from the disease.

Dr. Hal Barron, Chief Scientific Officer and President, R&D, at Glaxo, said, "Children with lupus have had limited options available to help treat their condition. This accelerated decision means children in the U.S. now have an innovative, FDA-approved medicine available to help manage the impact of living with this challenging autoimmune disease."

"The agency expedited the review and approval of this application because Benlysta IV fulfils an unmet need for therapies, specifically in pediatric patients with SLE. While there is no cure for lupus, treatment can help our youngest patients control their disease with the hope of improving their quality of life and lowering their risk of long-term organ damage and disability," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

April 26, 2019 16:16 ET (20:16 GMT)

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