The EC approval is based on data from the Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy (PLUTO) study
Image: GlaxoSmithKline head office, London, UK. Photo: Courtesy of Ian Wilson/Wikipedia.
GlaxoSmithKline (GSK) has secured approval from the European Commission (EC) to extend its existing adult indication for intravenous Benlysta (belimumab) to children aged five years or older.
Benlysta (belimumab) is used as an additional therapy for patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity.
SLE is a chronic, incurable, autoimmune disease characterised by a variety of symptoms including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage.
GSK R&D president and chief scientific officer Hal Barron said: “Children with lupus typically have more severe disease and earlier onset of organ damage than adults, but until now their treatment options have been limited.
“This approval means that for the first time in Europe these children can be treated with a biologic therapy specifically developed and approved for their disease.”
Benlysta is the first biologic treatment approved for children with lupus
Benlysta is a human monoclonal antibody that binds to soluble BLyS to inhibit the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
The UK-based pharmaceutical firm said that its Benlysta is currently the only medicine specifically developed and approved SLE treatment for adults, and now for 5 years and older children in Europe.
The EC has extended the Benlysta indication to children aged five years and older, following its approval as an IV formulation in July 2011, and as a subcutaneous (SC) formulation in November 2017.
GSK said that the EC approval, following the US and Japan approvals, is based on data from the paediatric lupus trial of Belimumab plus background standard therapy (PLUTO) study, to evaluate the efficacy, safety and pharmacokinetics of IV belimumab.
Lupus Europe general secretary Alain Cornet said: “This decision is great news for the lupus community in Europe and 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.”