29th Oct 2019 17:03
(Alliance News) - GlaxoSmithKline PLC said on Tuesday the European Commission has decided to extend the adult indication for intravenous Benlysta to children aged five and over.
Intravenous Benlysta is an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.
Glaxo noted intravenous Benlysta is the first biologic treatment to be approved for children with lupus in Europe.
This approval by the European Commission follows recent approvals in the US and Japan, all supported by data from PLUTO, a post-approval commitment study.
Hal Barron, chief scientific officer & president, R&D said: "Children with lupus typically
have more severe disease and earlier onset of organ damage than adults, but until now their
treatment options have been limited. This approval means that for the first time in Europe these
children can be treated with a biologic therapy specifically developed and approved for their disease."
By Lucy Heming; [email protected]
Copyright 2019 Alliance News Limited. All Rights Reserved.
Related Shares:
Glaxosmithkline