GSK Benlysta gets European nod for treatment of children with lupus
New Delhi: GlaxoSmithKline (GSK) plc recently announced that the European Commission has adopted a decision to extend to children five years and older, the existing adult indication for intravenous Benlysta (belimumab) as add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.
In its latest press release, GSK said, "This approval by the European Commission follows recent approvals in the US and Japan, all supported by data from PLUTO, a post-approval commitment study."
Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Benlysta does not bind B cells directly. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Benlysta is currently the only medicine specifically developed and approved for SLE for adults in Europe. It was approved as an IV formulation in July 2011, and as a subcutaneous (SC) formulation in November 2017. Benlysta IV approval has now been extended to children.
IV Benlysta is indicated in the European Union as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy.
The Benlysta subcutaneous formulation is not approved for use in children in the EU or elsewhere in the world.
Commenting on the same, Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK 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."
Alain Cornet, General Secretary of Lupus Europe, a charity supporting people with lupus in Europe, commented, "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."
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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. In children, this disease is associated with more rapid accrual of damage and has a higher degree of morbidity compared with systemic lupus erythematosus in adult populations.
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