GlaxoSmithKline files for EU approval of new rheumatoid arthritis drug

GlaxoSmithKline has filed for European regulatory approval of sirukumab, a human anti-interleukin-6 monoclonal antibody therapy for rheumatoid arthritis.

A marketing authorisation application has been submitted to the European Medicines Agency seeking approval of a subcutaneous formulation of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

The drug is intended for use in combination with methotrexate in patients who have failed or are intolerant to conventional or biologic disease-modifying antirheumatic drugs, and as a monotherapy among patients for whom treatment with methotrexate is inappropriate.

Developed in collaboration with Janssen Biologics, sirukumab has demonstrated its safety and efficacy across five phase III clinical trials.

Paul-Peter Tak, GlaxoSmithKline's chief immunology officer and senior vice-president of its research and development pipeline, said: "We have worked with our partner Janssen to develop a robust regulatory package to support the use of sirukumab in adult patients who, despite the use of conventional and biologic therapies, still suffer from moderately to severely active rheumatoid arthritis.”

The company also plans to apply for US regulatory approval of the drug later this year.

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