In an interview by MedicalResearch.com, Dr. Thomas S.G. Sehested, MD Department of Cardiology, Copenhagen University Hospital, and Dr. Jenny Bjerre, Department of Cardiology, Copenhagen University Department of Health Research and Policy, as well as Stanford University School of Medicine, discussed Novartis’ Canakinumab and the results from the “CANTOS” trial. The inflammatory hypothesis (that targeting inflammation can reduce cardiovascular disease) was confirmed.
As reported by MedicalResearch.com, Novartis’ trial tested the monoclonal antibody with post-myocardial infarction patients with elevated inflammation markers (hs-CRP). Presently, the treatment (canakinumab) is used for rare diseases and is priced as an orphan drug at $73,000 per year for the 150mg dose. However, the Danish physicians concluded that the price of canakinumab would need to be cut by more than 98% to achieve commonly accepted cost-effectiveness threshold. Based on this research, the drug price for one quality-adjusted life-year added would be $6.4 million.
Another recent Evaluate report, authored by Madeline Armstrong, notes that the expensive canakinumab cardiovascular program has been a dead end, and now the Swiss sponsor may seek to study its effect with cancer patients. Canakinumab (trade name IIaris) is a human monoclonal antibody targeted at interleukin-1 beta. It has no cross-reactivity with other members of the interleukin-1 family. It was approved for the treatment of cryopyrin-associated periodic syndromes (CAPS) by the FDA in June 2009; EMA also approved in 2009. CAPS is a spectrum of autoinflammatory syndromes including familial cold autoinflammatory syndrome, Muckle-Wells syndrome, and neonatal-onset multisystem inflammatory disease. In 2016 the FDA approved the use of canakinumab on three additional rare and serious auto-inflammatory diseases including:
- Tumor necrosis factor receptor associated periodic syndrome (TRAPS)
- Hyperimmunoglobulin D syndrome (HIDS)
- Mevalonate kinase deficiency (MKD)
- Familial Mediterranean fever (FMF)
Canakinumab is also in clinical trials for several other indications. On August 27, 2017, the results of the CANTOS trial were announced at the European Society of Cardiology and published in Lancet and the New England Journal of Medicine. Those treated in CANTOS had a 15% reduction in deaths from heart attacks, stroke and cardiovascular disease combined. However, there were also serious side effects reported and no statistically significant overall survival benefit. David Goff, director of the division of cardiovascular sciences at the National Heart, Lung and Blood Institute, articulated the enormous potential for the drug noting “public health impact potential is really substantial.” Further data showed that a significant reduction in lung cancer incidence and mortality in the CANTOS canakinumab treated group, compared to placebo.