Novartis’ Cosentyx is the first IL-17 inhibitor to win US approval for ankylosing spondylitis and psoriatic arthritis, offering a new approach to treating two of the most common inflammatory joint conditions, for which there remains high unmet need.
AS and PsA are life-long, painful and debilitating inflammatory diseases affecting the joints and/or spine which, if not treated effectively, can lead to irreversible damage from years of inflammation.
They affect 0.5% and up to 1% of the US population, respectively, and there is an urgent need for new treatment options as up to 40% of patients fail to respond to standard of care biologics.
According to David Epstein, division head, Novartis Pharmaceuticals, Cosentyx (secukinumab) offers “a potential turning point” for AS and PsA patients, as clinical data shows it can significantly reduce signs and symptoms of these diseases and induce “major improvements” in the ability to undertake everyday activities.
Phase III studies included more than 1,500 adult patients with AS or PsA that were biologic treatment naïve or had an inadequate response/were intolerant to anti-TNF therapy. Cosentyx hit its key targets by achieving statistically significant improvements versus placebo in the signs and symptoms of both conditions, as measured by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria at Week 16, and a 20% reduction in the American College of Rheumatology (ACR 20) response criteria at Week 24, respectively.
The drug, a fully human monoclonal antibody, was also the first IL-17 inhibitor to win European approval for AS and PsA back in November, following clearance for plaque psoriasis on both sides of the Atlantic in January last year. It is widely expected to hit blockbuster status by 2020.