Belimumab application to NICE
On May 20, 2011 GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced 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.
A licence application was submitted by GSK to the National Institute for Clinical Excellence (NICE) and the appraisal was conducted during the summer.
NICE has issued a press release to say “NICE is provisionally unable to recommend belimumab for treating adult patients with active autoantibody-positive systemic lupus erythematosus, where patients have a high degree of disease activity despite the individual receiving standard therapy, in line with the drug's marketing authorisation.”
As part of the appraisal, NICE is conducting a consultation until October 21st and LUPUS UK will be making an official response and an appeal, if necessary, when the final decision is announced at the end of November. Click here for more information.
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