Novartis is falling farther behind AbbVie, which expanded its JAK inhibitor Rinvoq into giant cell arteritis in April.
Novartis’ anti-inflammatory antibody Cosentyx failed to improve remission in a Phase III trial of giant cell arteritis, dealing a blow to the pharma’s aspirations of challenging AbbVie’s Rinvoq in this indication.
Data provided in Thursday’s news release were scant. Novartis revealed only that Cosentyx was not able to significantly improve sustained remission at 52 weeks versus placebo. Secondary outcomes, including cumulative steroid dose and steroid-related toxicities, were likewise not statistically different between the Cosentyx and placebo arms, though Novartis detected “numerically better outcomes” with its drug.
These findings come from the Phase III GCAptAIN study, which enrolled more than 350 patients with giant cell arteritis (GCA) who were given either 300 mg or 150 mg of Cosentyx, plus a 26-week steroid taper. Comparators were given placebo and a 52-week steroid taper.
Novartis on Thursday did not disclose regulatory plans for Cosentyx in GCA, only revealing that it is still conducting a full analysis of GCAptAIN and will share full findings “at a later date.”
In an April 16 note to investors, analysts at Guggenheim Partners named the GCAptAIN readout as one of the “catalysts” to watch for from Novartis this year as the pharma tries to challenge AbbVie in the inflammation space.
Thursday’s Phase III fail is a heavy setback for Novartis, especially after AbbVie’s JAK inhibitor Rinvoq won the FDA’s nod for GCA in April. Late-stage data supporting the approval showed that 46.4% of patients treated with Rinvoq plus a 26-week steroid taper achieved sustained remission from weeks 12 through 52, as opposed to 29% of placebo comparators. The treatment effect was statistically significant.
Also known as temporal arteritis, giant cell arteritis is an autoimmune condition characterized by the inflammation of various blood vessels, including those in the temple. Patients often suffer from vision problems, fatigue and bad headaches. Both Cosentyx and Rinvoq target the inflammation underlying the disease: Cosentyx targets and blocks IL-17A, a cytokine involved in triggering the inflammatory response, while Rinvoq inhibits Janus kinases, enzymes that help transmit signals from the cytokines acting on the cell membrane toward the inner part of the cell. Also approved to treat GCA is Roche’s Actemra, an inhibitor of the IL-6 receptor.
According to analysis by the IMARC Group, a management consulting firm, the GCA market was worth $1.1 billion in 2024 and is expected to grow to over $1.8 billion by 2035.
