GSK today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the use of intravenous (IV) Benlysta (belimumab) as an add-on therapy in children aged five years and older with active, autoantibody-positive systemic lupus erythematous (SLE) with a high degree of disease activity.
This opinion for Europe follows the recent approval by the Food and Drug Administration in April 2019 of the IV formulation of Benlysta in the US for children aged five years and above with lupus. A CHMP positive opinion is one of the final steps before a marketing authorisation decision is made by the European Commission.
If approved by the European Commission, children in Europe with lupus who are five years and older, will for the first time have a medicine specifically developed and approved to treat this challenging autoimmune disease.
