ZURICH (Reuters) - Novartis plans to plow through doubts over its canakinumab drug by asking regulators this year to approve the medicine as a treatment for a group of heart attack survivors that the Swiss drugmaker says is most likely to benefit.
New analysis of Phase III data shows canakinumab cut risk of another adverse cardiac event by 25 percent in patients whose inflammatory markers fell significantly three months after starting treatment, Novartis said on Monday, adding the group represented 55 percent of those in the so-called Cantos trial.
That tops the overall 15 percent risk reduction reported in August for all patients in the six-year trial that included more than 10,000 heart attack survivors.
Novartis’s trial has been lauded as revolutionary for helping prove fighting inflammation - not merely lowering cholesterol - helps heart attack victims avoid future adverse events or death.
Still, some cardiovascular experts have so far concluded canakinumab’s benefits are insufficient to justify expanding its existing approvals for rare inflammatory diseases to routine use in cardiac patients.
On Monday, Novartis went on the counter-attack at an American Heart Association meeting in California, contending its new analysis underpinned canakinumab’s value as a targeted therapy.
“We are absolutely of the mind that we want this be a targeted medicine,” Vasant Narasimhan, Novartis’s drug development chief who takes over as CEO in February, said on a conference call.
“If ... we would not have the opportunity to target this medicine, we would ultimately reconsider whether we would bring this medicine to market.”
The potential market is immense, with a quarter of the 1.3 million people who suffer heart attacks in the United States and Europe annually likely to have another cardiovascular event within five years.
Still, one challenge Novartis faces with canakinumab, also known as Ilaris, is it now costs some $200,000 annually for treating rare inflammatory diseases. Cardiology drugs command a fraction of that.
Consequently, Novartis must ensure sufficient eligible heart patients to make a price cut worthwhile, while also establishing a robust benefit profile necessary to convince insurers to pay what will still be a hefty tab.
Doubts have plagued new cardiovascular drugs, with ongoing debate over whether new PCSK9 cholesterol-lowering injections are worth their roughly $15,000-per-year price tags.
Novartis is keenly aware of heart-drug hurdles, too, after sluggish uptake of its $4,500-per-year Entresto, despite trial results in heart failure that were lauded as stellar.
While Basel-based Novartis has highlighted canakinumab’s cancer-fighting properties in tumors that thrive on inflammation, Narasimhan acknowledged those preliminary findings would play a limited role with regulators until more studies are completed.
“We believe we’ll be able to reflect the cancer findings to some extent in the safety sections of the labels for canakinumab, but it wouldn’t be in the efficacy section,” he said.
Reporting by John Miller; Editing by Mark Potter