Positive pivotal Lilly data set stage for Taltz approval in non-radiographic axial spondyloarthritis

Having secured approval for psoriatic arthritis and plaque psoriasis, Lilly is plotting to get its monoclonal antibody Taltz across the finish line for a form of inflammatory arthritis in which there is no visible evidence of damage on X-rays — non-radiographic axial spondyloarthritis (nr-AxSpA). On Monday, the drugmaker reported the treatment had cleared a late-stage study, setting the stage for a regulatory submission later this year.

Taltz, akin to Novartis’ blockbuster Cosentyx, inhibits IL-17A, a cytokine involved in inflammatory and immune responses. The drug generated $937.5 million last year.

Non-radiographic axial spondyloarthritis (nr-AxSpA) falls under an umbrella category of spondyloarthritis, which encompasses various forms of arthritis with one distinguishing feature: There’s almost always inflammation in the spine.

The condition often affects the bones and joints at the base of the spine where it connects with the pelvis. When the disease is active, these joints become inflamed.

In the COAST-X trial, Taltz induced a statistically significant improvement in the signs and symptoms of nr-axSpA at both week 16 and week 52, versus placebo. The drug also met the study’s secondary goals.


“The COAST-X data add to the growing body of evidence from our COAST program, which demonstrates that Taltz may work across the axSpA disease spectrum…which support our belief that Taltz could become the first IL-17A antagonist to be approved in the U.S. for people with non-radiographic axSpA,” said Christi Shaw, president of Lilly Bio-Medicines, in a statement.

Cosentyx, one of Novartis’ key drugs, is also being evaluated as a treatment for nr-AxSpA. UCB’s Cimzia was the first therapy in the United States to win FDA approval — last month — for the often underdiagnosed patient population.

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Skyhawk Therapeutics Waltham, MA
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