Potential Rheumatoid Arthritis Blockbuster Gets First Approval

Sanofi and Regeneron can today count a victory in the race to market a new generation of rheumatoid arthritis (RA) drugs. Sarilumab (product name Kevzara) has been approved for sale by Health Canada.

The companies anticipate rulings from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) later in 2017, with the FDA decision expected in the first quarter of the year.

Sarilumab is a fully human monoclonal interleukin-6 (IL-6) antibody, which works by binding to IL-6 receptors to inhibit its production and release. IL-6 is a cytokine that can “promote synovitis and joint destruction by stimulating neutrophil migration, osteoclast maturation and vascular endothelial growth factor (VEGF)-stimulated pannus proliferation,” according to studies.

Sanofi and Regeneron’s entry is not the only upcoming drug clamoring for a slice of the huge RA treatment market. GlaxoSmithKline submitted an application to the FDA in September for sirukumab, another monoclonal IL-6 antibody. A third entry, clazakizumab, was licensed by Alder to newcomer Vitaeris earlier this year. Tocilizumab, produced by Roche and marketed as Actemra, is the only drug of the class already on the market.

All seem to be hunting a slice of the behemoth adalimumab’s market share. Sold by AbbVie as Humira, it’s the world’s best-selling drug, with approvals for RA, plaque psoriasis, psoriatic arthritis, Crohn’s disease, and non-infectious uveitis, among other conditions.

Sarilumab has been tested head-to-head against adalimumab a few times in clinical trials, most recently outperforming the market-leader in 28-joint disease activity score (DAS28) improvement at 24 weeks in a German phase 3 trial published in November. When topline results of that study were announced in the spring, AbbVie objected, pointing out that the comparison was of the two as monotherapies, and that their drug is typically taken in combination with a disease-modifying anti-rheumatic drug (DMARD) like methotrexate.

Health Canada’s approval of sarilumab was based on trial data from over 2,900 adults with moderate or severe RA who previously had inadequate responses to other treatments. A press release regarding the decision stated that the drug “demonstrated clinically-meaningful improvements, either as monotherapy or in combination with conventional DMARDs, including methotrexate, in reducing signs and symptoms, improving physical function, and inhibiting radiographic progression of structural damage of RA in approximately 1,743 patients.”

The release quotes Dr. William Bensen, a Clinical Professor of Rheumatology at Ontario’s McMaster University, describing sarilumab as a welcome new therapy that “works differently from the most commonly used biologics.”

The Canadian approval is a step along the path for a drug that analysts believe, and its makers hope, may someday be a billion-dollar seller. The announcement was made today in a press release.

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