GlaxoSmithKline files for US and EU approval of Benlysta for lupus

GlaxoSmithKline has announced that it has applied for regulatory approval of Benlysta as a therapy for systemic lupus erythematosus in the US and Europe.

Regulatory submissions have been filed with the US Food and Drug Administration and the European Medicines Agency seeking approval of subcutaneous Benlysta in the treatment of patients with active autoantibody-positive systemic lupus erythematosus.

These filings are based on phase III pivotal study data from the BLISS-SC trial, which evaluated Benlysta administered weekly via subcutaneous injection plus standard of care compared to placebo.

Regulatory filings in other countries are planned during the course of 2016 and 2017. The subcutaneous formulation of Benlysta has not yet been approved for use anywhere in the world.

Paul-Peter Tak, chief immunology officer and senior vice-president for GlaxoSmithKline's research and development pipeline, said: "If approved, a subcutaneous formulation of Benlysta would provide an alternative approach to treatment administration, helping to address the individual needs of lupus patients."

Benlysta is the first medicine specifically developed and approved for the treatment of systemic lupus erythematosus in more than 50 years.

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