With new data at hand, Novartis to file for canakinumab heart indication this year

In addition to a wealth of previous data, Swiss pharma giant Novartis (NOVN: VX) has now published a new analysts of a Phase III trial of its canakinumab and said that it expects to file for regulatory approval of the drug this year as a treatment for a group of heart attack survivors that are most likely to benefit.

Canakinumab is a monoclonal antibody that is already approved for a few rare inflammatory conditions and is marketed under the trade name Ilaris.

The new analysis of the Phase III CANTOS study was presented by Dr Paul Ridker at the American Heart Association (AHA) Scientific Sessions 2017 and published simultaneously in The Lancet.The pre-planned secondary analysis of an exploratory endpoint showed that people with a prior heart attack who achieved hsCRP levels below 2mg/L at three months after the first dose of canakinumab had a 25% reduction in major adverse cardiovascular events (MACE) versus placebo (HRadj=0.75, 95% CI 0.66-0.85, p<0.0001).