Eli Lilly’s Taltz has followed Novartis rival Cosentyx into all the diseases it treats. But this time, Lilly wants to be first.
Monday, the Indianapolis drugmaker trumpeted phase 3 data showing its IL-17 med nailed its key goals in a phase 3 trial in non-radiographic axial spondyloarthritis (nr-axSpA), a chronic inflammatory condition. And those results “support our belief that Taltz could become the first IL-17A antagonist to be approved in the U.S.” to treat it, Christi Shaw, president of Lilly Bio-Medicines, said in a release.
Lilly plans to submit the data to regulators this year in hopes of that green light, but it’ll be a tight race, with Novartis’ Cosentyx also already in phase 3 for the same indication.
Taltz went up against placebo in the so-called Coast-X trial, which focused on patients who'd never before been treated with a biologic disease-modifying drug. The outcome? Taltz posted statistically significant improvements in nr-axSpA signs and symptoms at both the 16-week mark and the 52-week mark, the trial's two primary endpoints.
The drug also hit its marks in the secondary endpoint category, posting improvements in a number of metrics commonly used to evaluate the disease, including the Ankylosing Spondylitis Disease Activity Score.
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Taltz’s performance follows up on two positive trials from last year in ankylosing spondylitis, a separate subset of axSpA patients defined by structural joint damage that shows up on radiographic scans.
"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," Shaw’s statement said.
In that field, though, Taltz is chasing down Cosentyx, which has been on the ankylosing spondylitis market for more than three years. And Lilly is still waiting for the FDA's word on Taltz in that indication, which it expects later this year.
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If Lilly can grab the spondylitis nod, it’ll mark the third frontier for its Cosentyx battle. Taltz also followed the Novartis blockbuster into plaque psoriasis and, in late 2017, psoriatic arthritis.