FDA Declines Canakinumab to Prevent CVD

By Kaitlyn D’Onofrio - October 22, 2018

The U.S. Food and Drug Administration (FDA) has rejected canakinumab to be used to reduce the risk of cardiovascular disease (CVD). 

“Based on the correspondence, the Cantos data would not support labeling for the use of canakinumab as a targeted therapy for those patients with cardiovascular disease who achieved a reduction of hsCRP below the 2 mg/L target,” drug manufacturer Novartis said in a statement. 

Canakinumab, a interleukin-1β inhibitor sold under the brand name Ilaris, was previously approved to treat systemic juvenile idiopathic arthritis. In 2017, Novartis’ CANTOS trial, a randomized, double-blind trial, compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every three months) with placebo in 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level (≥ 2 mg/L). Hazard ratios compared with placebo were 0.93 in the 50-mg group (95% confidence interval [CI], 0.80 to 1.07; P = 0.30), 0.85 in the 150-mg group (95% CI, 0.74 to 0.98; P = 0.021), and 0.86 in the 300-mg group (95% CI, 0.75 to 0.99; P = 0.031). All-cause mortality did not differ between the canakinumab groups and the placebo patients (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31), and canakinumab was associated with greater risk of fatal infection than placebo. 


Canakinumab costs about $200,000 annually to treat inflammatory disorders. 

“We’re now evaluating the full details of what’s in the complete response letter, and trying to determine what is the best course of action,” a Novartis spokesman said to Reuters. “It’s not clear what the next steps are.” 

The CVD trials found evidence that canakinumab may carry benefits for lung cancer patients, and Novartis said it will continue studying this possibility. 

Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials 

Relationship of Interleukin-1β Blockade With Incident Gout and Serum Uric Acid Levels: Exploratory Analysis of a Randomized Controlled Trial 

Interleukin-1β Blockade With Incident Gout and Serum Uric Acid Levels: What’s the Relationship? 

SourcesMedPage Today, Medscape, Reuters, NEJM

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