Novartis’ Cosentyx is in a heated contest with Eli Lilly’s Taltz for IL-17A inhibitor supremacy, duking it out in three indications. Now, with new phase 3 data in spondyloarthritis, Novartis wants to make it four.
Cosentyx topped placebo at cutting down activity and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) at 16 weeks of treatment, according to phase 3 trial data released Tuesday. The 555 patients in the trial, dubbed Prevent, had taken at least two different non-steroidal anti-inflammatory drugs prior to treatment, but around 90% of those treated had never taken a biologic, Novartis said.
Novartis has submitted its Prevent data to European Medicines Agency (EMA) regulators for approval and plans to present its findings in detail at an upcoming medical meeting. Follow-up Prevent data at 52 weeks is expected for release later this year and could be used as the basis for an FDA submission, Novartis said.
If Cosentyx wins a European nod, it would be the IL-17A inhibitor’s fourth indication alongside psoriatic arthritis (PsA), ankylosing spondylitis (AS) and psoriasis. Those wins matter for Cosentyx: Rival classmate Taltz trailed it to market in the other indications but holds the lead in nr-axSpA. Taltz hit its primary endpoints in a phase 3 nr-axSPA trial of its own in April, giving the drug a five-month head start on its older competitor.
In that trial, known as Coast-X, Taltz posted symptom improvements at both the 16-week and 52-week marks, 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.
That wasn’t the only good news for Taltz this year: In late August, the med scored an FDA nod of its own in AS, matching Cosentyx in approved indications and likely setting up a showdown between blockbusters.
On the back of approvals in PsA in from December 2017 and plaque psoriasis from March 2016, Taltz soared to $606.3 million in first-half sales this year, placing it well within range of $1 billion this year and projecting to easily best its $937.5 million finish from 2018.
Cosentyx, by contrast, hit $1.65 billion in sales in the first half, underscoring the drug’s significant head start in all the indications Taltz is challenging. Not only that, Cosentyx doesn’t appear to be ready to let up: The drug’s U.S. sales grew 33% in the second quarter over the same period in 2018.
Taltz has also aggressively going after immunology competitors in other classes, including megablockbuster Humira. In June, Lilly posted head-to-head phase 3 trial data showing Taltz bested Humira at reducing PsA 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, in early August showing its drug had topped Tremfya at achieving total skin clearance after 12 weeks of treatment.