Cosentyx (secukinumab), one of Novartis’ top-selling drugs, has failed to show efficacy in a Phase 3 trial of giant cell arteritis, an autoimmune disease affecting the blood vessels. The trial results were announced on 3 July and represent an unusual setback for a drug that has already been approved for seven immune-mediated inflammatory conditions. Cosentyx inhibits interleukin-17A and was first approved in the US in 2015 for plaque psoriasis. The name of the recent trial was GCAptAIN.
“While the Phase 3 results of GCAptAIN did not replicate the positive outcomes observed in the Phase 2 trial, we remain committed to continuing to drive scientific progress and deepening the understanding of immune-mediated diseases,” said Shreeram Aradhye, Novartis’ chief medical officer.
In the trial, patients were randomised into treatment arms of two different doses of Cosentyx and a steroid taper and a third placebo arm with the taper. The primary endpoint was to assess whether secukinumab was superior to placebo in achieving a sustained remission. The drug did not show a statistically significant improvement..
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