Novartis' Cosentyx lost a race against Eli Lilly's Taltz after the latter scored an FDA approval in spondyloarthritis earlier this week. But Cosentyx, which faces an FDA review in that indication, is touting long-term data that will help it keep the pressure on Lilly's rival.
The drug bested placebo at reducing the symptoms of non-radiographic axial spondyloarthritis in patients after 52 weeks, according to long-term data from the phase 3 Prevent study released Thursday at the European League Against Rheumatology (EULAR) meeting.
The 52-week data adds to earlier 16-week data that showed Cosentyx significantly reduced disease symptoms over placebo. More than 35% of patients treated with Cosentyx hit the study's primary endpoint of reducing a targeted set of disease symptoms 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 already filed for regulatory approval in the U.S. and Japan.
The newest Cosentyx data will keep things competitive with Lilly's Taltz, which scored an FDA approval earlier this week as the first IL-17 inhibitor green-lighted in that indication.
Taltz won its approval 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.
Non-radiographic axial spondyloarthritis is believed to affect more than 1 million U.S. patients each year, Lilly said. An FDA approval for Cosentyx would be the drug's fourth, as it was for Taltz; both drugs are also cleared in psoriatic arthritis, ankylosing spondylitis and psoriasis.
In March, UCB’s anti-TNF antibody Cimzia became the first FDA-approved drug for non-radiographic axial spondyloarthritis. But that drug carries a boxed warning about the increased risk of serious infections.
Lilly and Novartis are not only jockeying for position in spondyloarthritis. The companies are also battling it out across their other indications.
In June, Lilly posted head-to-head phase 3 trial data showing Taltz bested AbbVie's megablockbuster Humira at reducing psoriatic disease activity by half 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 in early 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.
Editors' Note: This story has been updated to correct an error.