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news.GlaxoSmithKline (GSK) and Human Genome Sciences (HGS) have received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency for Benlysta (belimumab).
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The CHMP has recommended the marketing authorization of Benlysta as an add-on therapy in adult patients who are suffering from active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy.
CHMP’S decision was based on two pivotal Phase 3 studies of belimumab (BLISS-52 and BLISS-76), which recruited around 1700 adult patients with autoantibody-positive active systemic lupus erythematosus.
GSK Research and Development chairman Moncef Slaoui said a positive recommendation from the CHMP is a major milestone in the clinical development programme for Benlysta.
"We look forward to the final decision from the European Commission regarding marketing authorisation and hope to bring this new medicine to appropriate patients in Europe," Slaoui said.