GSK Submits License Application for RA Medication Sirukumab


Sirukumab, a rheumatoid arthritis treatment that has performed well in recent studies, is now awaiting approval in both the United States and Europe.

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Following an announcement last week that the drug had been submitted to the European Medicines Agency (EMA) for consideration, GlaxoSmithKline today announced that it now seeks approval from the United States Food and Drug Administration (FDA) for sirukumab. Sirukumab is a new medication intended to treat rheumatoid arthritis (RA).

Developed in a joint venture with Janssen Biologics, the drug is a human anti-interleukin (IL)-6 monoclonal antibody, which works by binding to IL-6, a protein that’s at the center of many inflammatory conditions. GSK points to a series of recent phase III trials that engaged over 3,000 patients. Results showed slowing of joint degeneration at one year and improvements in RA symptoms in as few as 4 months.

Delivered as an injectable of either 50 or 100mg every four or two weeks, it is intended for use in those with moderate-to-severe RA who have seen little success with other disease-modifying antirheumatic drugs (DMARDs), though in some trials it has been administered in combination with older, traditional treatments.

GSK plans to release the findings of additional clinical studies at upcoming medical conferences.

Sirukumab, when and if approval is granted, will enter a crowding field of major new RA drugs. AbbVie’s Humira is already on the market and Sanofi’s sarilumab, which has performed well against Humira, was submitted for FDA consideration in January.

Rheumatoid arthritis affects over a million Americans and tens of millions worldwide.

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