Eli Lilly's Taltz beats Novartis to the punch with FDA approval in spondyloarthritis

Taltz
Eli Lilly's newest FDA-approved indication in non-radiographic axial spondyloarthritis is its fourth. (Eli Lilly)

Eli Lilly's Taltz and Novartis' Cosentyx have been jockeying for IL-17 inhibitor supremacy with back-and-forth FDA approvals for years. But in the race for a fourth indication, Taltz has come out on top—at least for now.

The FDA approved the Lilly drug to treat non-radiographic axial spondyloarthritis, making it the first IL-17 inhibitor in that indication.

The agency based its approval 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.

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Non-radiographic axial spondyloarthritis is believed to affect more than 1 million U.S. patients each year, Lilly said.

RELATED: Novartis' Cosentyx, Eli Lilly's Taltz cue new fight with spondyloarthritis data

Lilly will lean on its existing relationship with rheumatologists and identify new specialists for the indication to build Taltz's newest launch, Becki Morison, Lilly's vice president of U.S. immunology sales and marketing, said ahead of the approval.

One challenge Taltz will face is managing a successful launch during COVID-19—which has caused an industrywide upheaval for commercial operations—without adding to its commercial team.

Lilly's sales organization has had to adjust to a new reality of virtual meetings rather than in-person educational sessions and sales pitches. But Morison said the drugmaker is hoping to keep the gears moving until the pandemic passes.

"It’s not impossible, but it is different," Morison said of the modified launch. "Our normal channels of engaging at conferences or face-to-face interactions––those are just fewer now and in some cases have stopped."

In the meantime, Lilly will continue to work with patient advocacy groups and use awareness campaigns to reach out to patients about a disease that is difficult to detect.

RELATED: Eli Lilly's Taltz extends its head-to-head Humira beat with 52-week psoriatic arthritis data

Meanwhile, Taltz will have its run as the only IL-17 inhibitor in the market––but it could be a short one.

Cosentyx posted phase 3 data in November showing it reduced disease activity in 42.2% of patients at week 16, versus 29.2% for placebo. An eventual FDA approval for Cosentyx would give it a fourth approval, just like Taltz, including psoriatic arthritis, ankylosing spondylitis and psoriasis.

In March, UCB’s anti-TNF antibody Cimzia became the first drug FDA specifically approved 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 rheumatology, but also have their eyes set on another race.

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.

Morison said Lilly aims to maintain Taltz's position over Cosentyx by investing in clinical data and label expansions in the future. But Taltz's win in non-radiographic axial spondyloarthritis is more about patient benefit than a head-to-head market battle, she said.

"We think Taltz is a great option and we want physicians to look at Taltz, but really, at the end of the day, more is better for patients," she said.

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