Novartis and Eli Lilly have been jockeying for new indications and commercial success for their IL-17 inhibitors Cosentyx and Taltz, respectively. Lilly appeared to get the label-expansion edge with the FDA's blessing for a fourth indication earlier this month, but Novartis was hot on its rival's heels—and now has a Cosentyx approval to match.
The FDA Tuesday approved Cosentyx to treat adult patients with non-radiographic axial spondyloarthritis, just weeks after the agency approved Lilly's Taltz as the first IL-17 inhibitor in that indication. Cosentyx will now join the field to fight the condition, which affects more than 1 million U.S. patients each year, Novartis said.
The FDA based its review on data from the phase 3 Prevent trial that showed Cosentyx significantly reduced disease symptoms over placebo at four-month and one-year check-in dates. More than 35% of patients treated with Cosentyx saw their disease symptoms reduced at 52 weeks, compared with 19% of patients taking placebo. At 16 weeks, 42.2% of patients hit the same mark, versus 29.2% for placebo.
Cosentyx notched a European Medicines Agency approval to treat non-radiographic axial spondyloarthritis in April and has also filed for regulatory approval in Japan.
Taltz, meanwhile, scored its landmark approval in early June based on results from the phase 3 Coast-X trial, which showed 30% of patients treated with Taltz saw reduced targeted disease symptoms after 52 weeks of treatment compared with 13% of patients treated with placebo.
At 16 weeks, 35% of Taltz patients stayed above that mark, compared with 19% of placebo patients.
But the pair isn't alone in the disease area. In March, UCB’s anti-TNF antibody Cimzia became the first FDA-approved drug for non-radiographic axial spondyloarthritis. That drug, though, carries a boxed warning about the increased risk of serious infections.
Novartis newest indication marks its fourth approved by the FDA—matching Taltz's total from the agency.
As both Lilly and Novartis prep for battle in spondyloarthritis, the drugmakers will continue the fight between Taltz and Cosentyx in other arenas, too.
Earlier this month, Lilly posted head-to-head phase 3 trial data showing Taltz had bested AbbVie's megablockbuster Humira at reducing psoriatic disease activity by half among psoriatic arthritis patients and completely clearing patient skin after 24 weeks. Lilly also went after Johnson & Johnson's Tremfya in psoriasis with a round of phase 4 data, showing last August its drug had topped Tremfya at achieving total skin clearance after 12 weeks of treatment.
Meanwhile, Cosentyx posted middling results in November in a head-to-head matchup with Humira, failing to outdo AbbVie's behemoth in active psoriatic arthritis patients. While Cosentyx helped more patients numerically reach ACR20—a benchmark on a commonly used scale from the American College of Rheumatology to measure joint swelling and more—its lead wasn’t statistically relevant, Novartis said.