Core Insights - Novartis' late-stage study of Cosentyx for treating giant cell arteritis (GCA) failed to meet its primary endpoint of sustained remission at week 52 [1][3][4] Group 1: Study Results - The Phase III GCAptAIN study showed that Cosentyx combined with a 26-week steroid taper did not achieve a statistically significant improvement in sustained remission compared to placebo with a 52-week taper [3][4][5] - Cosentyx also missed secondary endpoints with statistical significance, although it demonstrated lower steroid exposure and consistent safety [4][6] Group 2: Drug Background and Market Impact - Cosentyx, first approved in 2015, has expanded its indications to include several conditions such as psoriatic arthritis and hidradenitis suppurativa [2] - In Q1 2025, Cosentyx sales increased by 18% to $1.53 billion, driven by new launches and volume growth in core indications [8] Group 3: Future Plans and Implications - Novartis plans to further analyze the full data from the GCAptAIN study and share results in the future [6] - Potential label expansions for Cosentyx in additional indications could drive further growth [8]
Novartis' Cosentyx Misses Primary Goal in Arteritis Phase III Study