Glaxo (GSK), Human Genome (HGSI) Recieve Positive Opinion from CHMP for BENLYSTA
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GlaxoSmithKline (NYSE: GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) reports that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for BENLYSTA (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy.
From the release: "he CHMP is responsible for conducting the assessment of medicines for which an EU-wide marketing authorisation is sought. As part of its assessment to determine whether or not belimumab meets the necessary quality, safety and efficacy requirements, the CHMP reviewed data from two pivotal Phase 3 studies of belimumab (BLISS-52 and BLISS-76), which enrolled nearly 1700 adult patients with autoantibody-positive active systemic lupus erythematosus. The final decision regarding approval rests with the European Commission; this decision is normally issued approximately two-to-three months after the CHMP opinion."
From the release: "he CHMP is responsible for conducting the assessment of medicines for which an EU-wide marketing authorisation is sought. As part of its assessment to determine whether or not belimumab meets the necessary quality, safety and efficacy requirements, the CHMP reviewed data from two pivotal Phase 3 studies of belimumab (BLISS-52 and BLISS-76), which enrolled nearly 1700 adult patients with autoantibody-positive active systemic lupus erythematosus. The final decision regarding approval rests with the European Commission; this decision is normally issued approximately two-to-three months after the CHMP opinion."
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