New pediatric indication for Benlysta in the USA

29 April 2019

The UK’s GlaxoSmithKline (LSE: GSK) has won US Food and Drug Administration approval for an intravenous version of Benlysta (belimumab), together with standard therapy, for children aged five and over with lupus.

The approval means that, for the first time, children in the USA with lupus can be offered a lupus-specific treatment option. The product is not approved in Europe or anywhere else for pediatric use.

GSK has steadily invested in developing Benlysta, with US approval in 2017 for a subcutaneous self-injection version of the therapy, as a treatment for systemic lupus erythematosus (SLE).

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