Cosentyx gains EU approval for new label extension

Novartis’ interleukin (IL)-17A inhibitor Cosentyx has gained an EU label update to include data for axial manifestations of psoriatic arthritis (PsA).

In a statement, Novartis said that the label update makes Cosentyx (secukinumab) the first biologic with proven efficacy in all six key manifestations of PsA, and also the only biologic with ‘fast and lasting’ relief of axial manifestations of PsA in a dedicated trial.

The label update includes data from the Phase IIIb MAXIMISE trial, which evaluated the efficacy and safety of Cosentyx in the management of axial manifestations of PsA.

The trial included 485 patients with PsA with axial involvement and consisted of two treatment periods – a placebo-controlled period from baseline to week 12, followed by an active treatment period from week 12 to week 52.

At week 12, placebo patients were re-randomised to subcutaneous Cosentyx 300mg or 150mg, given weekly for four weeks and every four weeks starting week 4.

The primary endpoint was the proportion of patients achieving an Assessment of SpondyloArthritis International Society 20 (ASAS20) response with Cosentyx 300mg at week 12.

The key secondary endpoint was ASAS20 response with Cosentyx 150mg at week 12 after superiority of Cosenytx 300mg was established.

The trial met both of its primary and key secondary endpoints, with 62.9% and 66.3 of patients treated with Cosentyx 300mg and 150mg versus 31.3% on placebo achieving the primary endpoint respectively.