European Commission Extends Approval for GSK’s Benlysta as Add-On Therapy for Children

The European Commission approved GlaxoSmithKline’s Benlysta (belimumab) as an add-on therapy for children five years and older with active, autoantibody-suppressive lupus with a high degree of disease activity.

Benlysta is currently Europe’s only approved medicine for lupus for adults. It was approved as an IV formulation in July 2011 and as a subcutaneous injection in November 2017.

The FDA approved Benylsta in April, making it the first approved treatment for pediatric patients with Lupus.