It's official: the FDA declined to approve canakinumab (Ilaris) for cardiovascular risk reduction on the strength of data from the CANTOS trial, according to drugmaker Novartis.
"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 [high-sensitivity C-reactive protein] below the 2 mg/L target," the company said in a statement. Initially, the company had buried the announcement in its .
The $200,000-a-year interleukin-1β inhibitor had been approved in 2013 for certain rare inflammatory disorders.
In 2017, CANTOS results showed the drug reduced cardiovascular events by 15% among more than 10,000 patients with a history of myocardial infarction followed for a median of 3.7 years. This was seen as validation of the inflammation hypothesis in heart disease, though the effect was modest and the drug made no noticeable dent in all-cause mortality.
That combination of small benefit and high price raised questions about Novartis's ability to actually sell the drug for this indication, but evidently the company thought it was worth the effort.
Investigators also found a decreased risk of lung cancer among canakinumab recipients. For that reason, Novartis said its phase III canakinumab trials in non-small cell lung cancer would continue and the first study would be completed in 2022.
Notably, the potential benefits of canakinumab come with an important trade-off: the drug was associated with an increased risk of fatal infection in CANTOS.
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