Novartis' Cosentyx Shows Positive Phase III Data in SpA, Paving Way for Fourth Indication

Compiled by Fan Dongdong

Novartis’ Cosentyx and Eli Lilly’s Taltz are locked in intense competition in the IL-17A inhibitor space. With the release of Phase 3 clinical trial (Prevent) data in spondyloarthritis, Novartis’ Cosentyx is poised to secure its fourth regulatory approval.

The PREVENT study aimed to evaluate the efficacy and safety of Cosentyx in patients with non-radiographic axial spondyloarthritis (nr-axSpA). Among the 555 participants enrolled, all had taken at least two different nonsteroidal anti-inflammatory drugs (NSAIDs) prior to treatment, while approximately 90% had never received biologic therapy. The results demonstrated that after 16 weeks of treatment, Cosentyx was superior to placebo in reducing disease activity and improving symptoms in patients with nr-axSpA, with statistically significant clinical benefits. The safety profile of Cosentyx in this trial was consistent with that observed in previous studies.

Novartis has submitted data from the Prevent trial to the European Medicines Agency (EMA) and expects to file a regulatory application with the U.S. Food and Drug Administration (FDA) later this year, while planning to disclose detailed results at upcoming medical conferences. The company stated that 52-week trial data for patients treated with Cosentyx are expected to be released later this year and will support the FDA submission. If Cosentyx ultimately secures EMA approval, it will gain its fourth indication, following approvals for psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. The potential approval of this new indication is critical for the drug’s future competitive landscape, as Eli Lilly’s Taltz appears to have temporarily taken the lead in axial spondyloarthritis.

In April this year, Eli Lilly announced that the clinical study COAST-X evaluating the anti-inflammatory drug Taltz in axial spondyloarthritis had met its endpoints. Patients treated with Taltz for 16 and 52 weeks showed statistically significant improvements in symptoms and signs. These trial results provide relatively favorable clinical evidence for the efficacy of Taltz in treating this type of disease.

Eli Lilly’s Taltz was first approved in the United States in March 2016, becoming the second IL-17A monoclonal antibody drug marketed in the U.S. after Novartis’ Cosentyx. Currently, Taltz is approved for indications including adult patients with active psoriatic arthritis and adult patients with moderate-to-severe plaque psoriasis.

In the first half of 2019, Taltz’s sales surged to $606.3 million. In comparison, Cosentyx delivered an even more impressive performance, with its sales reaching $1.65 billion in the same period.

However, Taltz has not withdrawn from the competition and is positioning itself against other immunology competitors, including the world’s best-selling drug, Humira. In June, Eli Lilly presented head-to-head Phase III trial data at the 2019 European Congress of Rheumatology, demonstrating that Taltz was superior to Humira in improving outcomes for patients with active psoriatic arthritis (PsA). In August, Eli Lilly announced the results of IXORA-R, a Phase IV head-to-head clinical study comparing Taltz with Johnson & Johnson’s Tremfya for the treatment of moderate-to-severe plaque psoriasis. The proportion of patients achieving complete clearance of skin plaques was higher with Taltz, and the Taltz group also showed superiority over the Tremfya group across all key secondary endpoints.

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Novartis' Cosentyx chases Eli Lilly's Taltz with new spondyloarthritis data