Posted on 20/08/2010 in Pharmaceutical Company Product News GlaxoSmithKline's new systemic lupus erythematosus drug is to be granted a priority review from a healthcare regulator.
The US Food and Drug Administration has deemed that Benlysta, developed by GlaxoSmithKline in association with Human Genome Sciences (HGS), represents a major advance in an underserved clinical area.
This comes as a boost to the partners' efforts to secure regulatory approval for the drug, for which it also submitted an application to the European Medicines Agency on June 4th 2010.
It comes after the successful completion of two phase III clinical trials of Benlysta, both of which yielded positive safety and efficacy results.
Dr Carlo Russo, senior vice-president of biopharmaceutical development for GlaxoSmithKline, said: "We look forward to continuing to work together with HGS to progress regulatory files and we hope that we will be able to deliver a new treatment option for patients living with lupus."
Earlier this month, GlaxoSmithKline was granted a restricted recommendation from the Scottish Medicines Consortium for use of its immune thrombocytopenic purpura treatment Revolade among certain patients. Other news stories from 20/08/2010
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