Posted by Michael Wonder on 22 Sep 2019
GSK receives positive CHMP opinion for intravenous Benlysta in children with lupus aged five years and above
20 September 2019 - GSK today announced that the EMA's CHMP has issued a positive opinion recommending the use of intravenous Benlysta (belimumab) as an add-on therapy in children aged five years and older with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.
This opinion for Europe follows the recent approval by the FDA in April 2019 of the intravenous (IV) formulation of Benlysta in the US for children aged five years and above with lupus.
The recommendation is based on data from a post-approval commitment study (the ‘PLUTO’ study), assessing the efficacy, safety and pharmacokinetics of 10 mg/kg IV belimumab plus standard therapy compared with placebo plus standard therapy for one-year in 93 children aged 5 – 11 years (n=13) and 12 – 17 years (n=80) with systemic lupus erythematosus.
