Expanded EU label for Benlyta now covers paediatric lupus patients
pharmafile | October 30, 2019 | News story | Research and Development, Sales and Marketing | Benlyta, Europe, GSK, Lupus, pharma
GlaxoSmithKline is celebrating the news that the European Commission has chosen to approve an expansion to the label of its BLyS-specific inhibitor Benlyta to include paediatric patients over the age of five in the add-on treatment of active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.
This expands the pool of five to 17-year-old patients eligible to receive intravenous Benlyta to between 3,000 and 6,000 in the European Union. Paediatric patients are particularly vulnerable in this disease group, which exhibits a higher morbidity rate compared to adult populations. The decision comes on the heels of similar approvals in both the US and Japan.
Supporting data illustrated that a “numerically higher” proportion of patients receiving Benlysta in addition to standard therapy achieved a “clinically meaningful” improvement in disease activity according to the SLE responder index response rate of 52.8%, compared to 43.8% with placebo plus standard therapy.
“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,” explained Alain Cornet, General Secretary of Lupus Europe. “We are thankful to the many patients who, by taking part in clinical trials, made such progress possible.”
Dr Hal Barron, Chief Scientific Officer and President, R&D at GSK, also commented: “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.”
Matt Fellows
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