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What trials demonstrate canakinumab biosimilar s efficacy in cardiovascular disease?

See the DrugPatentWatch profile for canakinumab

Based on the information provided, I was unable to find specific clinical trials that demonstrate the efficacy of a canakinumab biosimilar in cardiovascular disease. However, I did find information on the original canakinumab drug, which is a human monoclonal antibody used to treat certain types of inflammatory diseases. Canakinumab is marketed under the brand name Ilaris and is manufactured by Novartis.

Canakinumab has been studied in the context of cardiovascular disease in the CANTOS trial (Canakinumab Anti-Inflammatory Thrombosis Outcomes Study). This randomized, double-blind, placebo-controlled trial investigated the effect of canakinumab on cardiovascular events in patients with a history of myocardial infarction and elevated C-reactive protein levels. The study found that canakinumab reduced recurrent cardiovascular events, mainly due to a reduction in non-fatal myocardial infarction and need for revascularization [1].

Although the CANTOS trial focused on the original canakinumab drug and not its biosimilars, it does provide evidence for the potential of canakinumab in managing cardiovascular disease. Biosimilars are typically expected to have similar efficacy and safety profiles as their reference biologics, provided they meet regulatory requirements [2].

However, it is important to note that biosimilars undergo their own clinical trials to demonstrate their safety and efficacy. As of now, there are no publicly available clinical trial results specifically evaluating canakinumab biosimilars in cardiovascular disease.

Sources:
[1] Ridker, P. M., Everett, B. M., Thuren, T., Zalewski, A., MacFadyen, J. G., Neeman, M., ... & Libby, P. (2017). Antiinflammatory therapy with canakinumab for atherosclerotic disease. New England Journal of Medicine, 377(12), 1119-1131.
[2] U.S. Food and Drug Administration. (2019). Biosimilars: Information for Healthcare Professionals. <https://www.fda.gov/drugs/biosimilars/biosimilars-information-healthcare-professionals>
[DrugPatentWatch.com] DrugPatentWatch. Canakinumab (Ilaris) Patent & Biosimilar Competition Analysis. <https://www.drugpatentwatch.com/canakinumab-ilaris-patent-biosimilar-competition-analysis/>


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