The European Commission (EC) has granted an extension to GlaxoSmithKline’s (GSK) Benlysta (belimumab), making it available for children five years and older as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.
The drug was initially given a National Institute for Health and Care Excellence (NICE) nod back in 2016, but only under a managed access agreement between GSK and NHS England, which provided the drug at a discounted price, and on the condition that data was collected to help address remaining questions over its efficacy.
It was actually cleared by the European regulators back in 2011 for autoantibody-positive SLE but, until 2016 NICE had barred patients from accessing it on the NHS because on the belief that it did not represent a cost-effective use of resources.
The new decision follows recent approvals in the US and Japan, all supported by data from PLUTO, and is “great news for the lupus community in Europe”, commented Alain Cornet, general secretary of Lupus Europe.
He continued, “particularly for young people affected and their supportive families, that so much need new therapeutic options. We are thankful to the many patients who, by taking part in clinical trials, made such progress possible.”
There are estimated to be between 3,000 and 6,000 children aged five to 17 years old with systemic lupus erythematosus in the European Union, and in children the disease is associated with more rapid accrual of damage and has a higher degree of morbidity compared with systemic lupus erythematosus in adult populations.
It is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage.