Posted by Michael Wonder on 30 Oct 2019
Intravenous Benlysta is the first biologic treatment to be approved for children with lupus in Europe
29 October 2019 - GlaxoSmithKline today announced that the European Commission has adopted a decision to extend to children five years and older, the existing adult indication for intravenous Benlysta (belimumab) as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.
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.
