GSK submits European application for potential arthritis blockbuster

GSK confirmed on Monday that it applied to the European Medicines Agency for approval of a subcutaneous formulation of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

Sirukumab, a human monoclonal antibody that slows the progression of joint damage and lessens some symptoms of the disease, is the biggest-potential of the company's near-term immuno-inflammation portfolio.

Chief immunology officer Paul-Peter Tak said Glaxo and its partner on the project, Ireland's Janssen Biologics, had put forward a strong regulatory package based on tests on over 3,000 patients 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.

"We believe sirukumab, if approved, will provide these patients with a once every four week subcutaneous treatment option," he said.

Glaxo is also planning to make an US application for sirukumab, which is currently not approved as a treatment for any indication anywhere in the world, later in 2016.

Analysts at HSBC estimate GSK will generate around £155m from sirukumab in the next financial year, doubling the year after and hitting £1.5bn a year by 2022.