GlaxoSmithKline and J&J march toward the FDA with a new arthritis treatment

Partners GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ) posted positive Phase III results for an injected treatment for rheumatoid arthritis, plotting to submit the therapy for global approvals next year.

The treatment, sirukumab, is designed to tamp down inflammation by blocking a protein called interleukin-6, or IL-6, which plays a role in the inflammatory process key to autoimmune diseases including arthritis. The antibody therapy came through with positive results in a trio of late-stage studies on about 3,000 patients, GSK said. The two companies are holding off on disclosing full data until a scientific conference next year.

Now GSK and J&J are set to submit sirukumab to the FDA and other regulators in 2016, the companies said, and each is counting on the treatment to meaningfully contribute to future revenue. GSK, under pressure from analysts and investors after years of underperformance, touted sirukumab as among the most promising assets in its pipeline at an R&D event last month. And J&J has highlighted the therapy as a potential $1 billion asset.

Elsewhere in IL-6, partners Sanofi ($SNY) and Regeneron ($REGN) are awaiting FDA approval with sarilumab, an antibody that succeeded in a Phase III arthritis trial of its own. And Alder BioPharmaceuticals ($ALDR) is looking for a partner to help take its similar clazakizumab into Phase III in the same indication.

J&J invented sirukumab and partnered up with GSK in 2011 to split the costs and rewards of development in arthritis. Under the agreement, both companies have the option to test out the antibody in other indications, and GSK has started enrolling a Phase III trial to see whether it can make a difference in giant cell arteritis, an inflammatory disorder of the arteries.

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