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Novartis' plan to expand the market for its anti-inflammatory drug canakinumab (Ilaris) with a cardiovascular indication have encountered a problem with the US Food and Drug Administration (FDA).
Vas Narasimhan, chairman and CEO of Novartis, said at a recent meeting on quarterly results that he received a full response letter from the FDA and that the agency "had asked additional questions and asked for additional data on the respondent population "let's now assess what the next steps would be. "
Novartis has hoped for a label change for the subgroup of patients in the CANTOS study who responded to the drug with C-reactive protein levels of high sensitivity (hp-CRP) below the median and a 27% reduction of the risk of major cardiovascular events.
Overall, the risk of major cardiovascular events decreased by 15% with the interleukin-1β inhibitor, which involved nearly 10,000 atherosclerosis patients with a history of avian influenza, and the median hsp-CRP level was 4.20 mg / L).
Although some perceived the results as a major breakthrough in validating the theory of inflammation related to atherosclerosis, the excitement elicited by this drug has been tempered by an increased risk of atherosclerosis. fatal infections and by its annual price of about $ 65,000.
Canakinumab is already marketed for the treatment of rare autoimmune diseases, but had already been rejected by the FDA for the treatment of gout for safety reasons.
CANTOS also unexpectedly reported that canakinumab reduced lung cancer and lung cancer mortality rates, and Narasimhan quickly pointed out that "we are continuing our lung cancer studies" in the adjuvant metastatic parameters, first and second intention. , with results expected in 2 to 4 years.
That said, Novartis is still facing the expansion of the canakinumab market, which is expected to lose patent protection in 2024.
Follow Patrice Wendling on Twitter: @pwendl. For more information on theheart.org, follow us on Twitter and Facebook.
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