Plans for Canakinumab CV Indication Hit Roadblock With FDA

Patrice Wendling

October 18, 2018

Novartis' plans to expand the market for its anti-inflammatory drug canakinumab (Ilaris) with a cardiovascular indication have hit a snag with the US Food and Drug Administration (FDA).

Speaking during a recent quarterly earnings meeting, Vas Narasimhan, the chief executive officer of Novartis, said it had received a complete response letter from the FDA and that the agency "has asked additional questions and requested additional data with respect to the responder population and we're evaluating now what would be the appropriate next steps."

Novartis pegged its hopes for the label change on the subgroup of patients in the CANTOS trial who responded to the drug with lower-than-median levels of high-sensitivity C-reactive protein (hs-CRP) and had a 27% reduction in the risk for major cardiovascular events.

Overall, the risk for major cardiovascular events declined by 15% with the interleukin-1β inhibitor in the trial, which enrolled nearly 10,000 patients with atherosclerosis, a history of MI, and persistently elevated hs-CRP level of at least 2.0 mg/L (median, 4.20 mg/L).

Although the results were viewed by some as a major step forward toward validation of the inflammation theory of atherosclerosis, enthusiasm for the drug was tempered by an increased risk for fatal infections and its roughly $65,000 annual price tag.

Canakinumab is already marketed for the treatment of rare autoimmune disease but was previously rejected by the FDA for the treatment of gout because of safety concerns.

CANTOS also unexpectedly reported that canakinumab cut rates of new lung cancer and lung cancer mortality, and Narasimhan was quick to point out that "we continue on track with studies in lung cancer" in the adjuvant, first-line, and second-line metastatic settings, with results expected in 2 to 4 years.

That said, Novartis still faces a steep challenge in broadening the market for canakinumab, which is slated to lose patent protection in 2024.

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