Novartis' canakinumab cuts risk for heart attack survivors

A drug currently marketed as an anti-inflammatory treatment could be Novartis' next cardiovascular blockbuster, after it showed success in cutting risk for heart attack survivors.

Canakinumab is the active ingredient in Novartis’ Ilaris, used to treat a range of inflammatory conditions including periodic fever syndromes and gouty arthritis.

But the Swiss drugmaker has also been developing the interleukin-1beta (IL-1b) inhibitor in a new formulation to treat people with prior heart attack and inflammatory atherosclerosis.

Novartis said it is the first and only agent which has shown that selectively targeting inflammation significantly reduces cardiovascular risk in patients who have had a prior heart attack and have an increased cardiovascular inflammatory burden.

The phase 3 CANTOS study investigated the efficacy, safety, and tolerability of canakinumab, also known as ACZ885, in combination with standard of care, in the new indication.

The goal was to see whether canakinumab reduces risk of major cardiovascular events – a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, in patients with a prior heart attack and inflammatory atherosclerosis.

Novartis said the study met its primary endpoint and will present details at a medical congress and in a peer reviewed publication later this year.

The company’s chief medical officer, Vas Narasimhan, noted that about 25% of heart attack survivors will have another cardiovascular event within five years.

[caption id="attachment_23888" align="alignnone" width="270"] Vas Naramsimhan[/caption]

Narasimhan added: "ACZ885 is the first and only investigational agent which has shown that selectively targeting inflammation reduces cardiovascular risk. Our priority now is to thoroughly analyse these important data and discuss them with regulatory agencies."

Canakinumab is a selective, high-affinity, fully human monoclonal antibody that inhibits IL-1b, a key cytokine in the inflammatory pathway known to drive the continued progression of inflammatory atherosclerosis.

It works by blocking the action of IL-1b for a sustained period of time, therefore inhibiting inflammation that is caused by its over-production.

In cardiology, Novartis already markets Entresto (sacubitril+valsartan), used to treat patients with heart failure with reduced ejection fraction.

Entresto is the first approved medicine of its kind and has been recommended in US and EU clinical guidelines.

It works by reducing the strain on the failing heart by enhancing the protective the protective neuro-hormonal systems, such as the natriuretic peptide system, while simultaneously inhibiting harmful effects of the overactive renin-angiotensin-aldosterone system.