GlaxoSmithKline receives positive CHMP opinion on Benlysta

GlaxoSmithKline has been granted a recommendation for European regulatory approval of its drug Benlysta as a treatment option for patients with autoantibody-positive active systemic lupus erythematosus.

The company and its partner Human Genome Sciences have won a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for approval of the product as an add-on therapy.

It follows a review of data from two pivotal phase III clinical trials of Benlysta, which satisfied the CHMP that the drug meets the required standard of quality, safety and efficacy.

A final decision is expected to be taken by the European Commission within the next two to three months.

Dr Moncef Slaoui, chairman for research and development at GlaxoSmithKline, said: "A positive recommendation from the CHMP is a major milestone in the clinical development programme for Benlysta."

Earlier this year, GlaxoSmithKline and Valeant Pharmaceuticals were granted European Commission approval for a new epilepsy therapy called Trobalt.