Pharma

Novartis’ next blockbuster? New drug cuts heart failure death rate a stunning 20 percent

Novartis could be on the verge of its next blockbuster. The Swiss pharma giant’s new heart failure […]

Novartis could be on the verge of its next blockbuster.

The Swiss pharma giant’s new heart failure drug could prove to replace the current standard of therapy, the company announced Saturday.

A wide-spanning heart failure study found that Novartis’ drug candidate LCZ696 cut cardiovascular deaths by 20 percent when compared to ACE-inhibitors, which have been the go-to heart failure treatment for more than two decades.

Its safety profile beats the “gold standard” of ACE-inhibitor treatment, a drug called enalapril, said Dr. Milton Packer, a professor of clinical sciences at the University of Texas Southwestern Medical Center in Dallas and one of the two principal investigators in the study.

“We designed this trial to replace ACE inhibitors in the treatment of heart failure – drugs that are used in about 90 percent of patients with heart failure,” Packer said. “Our results apply to the vast majority of people with this disease.”

More than 5 million Americans are diagnosed with heart failure, according to the CDC, with up to 26 million across the U.S. and Europe. Without question, the treatment falls into a multibillion dollar market – and because the drug’s proprietary and patented, it’ll likely be expensive. Novartis will file an NDA with the Food and Drug Administration by the end of 2014, a spokeswoman said.

This is likely welcome news for Novartis, which will be losing several of its top-selling drugs to the patent cliff next year – cancer drug Gleevec, for instance, goes off-patent in July 2015. It brings in revenues of nearly $5 billion.

The landmark heart failure trial’s results were presented at the European Society of Cardiology congress in Barcelona, Spain and published Saturday by The New England Journal of Medicine.

In the largest heart failure trial ever conducted – studying more than 8,400 patients over the course of three years – Novartis compared LCZ696 to enalapril, and also found that 21 percent less people were hospitalized when taking the new form of therapy. The drug had some impact on comorbidities as well – the all-cause mortality rate dropped by 16 percent.

Heart failure is a condition in which the heart can’t pump enough blood to the rest of the body, with symptoms like breathlessness, fatigue and fluid retention growing worse as time progresses – significantly impacting one’s quality of life.

The twice-a-day tablet is thought to help reduce strain on a failing heart, boosting protective neurohormonal systems in the heart while concurrently suppressing adverse effects, caused by the renin-angiotensis-aldosterone system.

ACE-inhibitors by contrast slow down the failure portion of heart failure, but the pace of health decline and death rate remain quite high, with about half of all patients dying within 5 years of diagnosis.

Packer simplified its mechanism of action:

The best way of thinking of this drug is: When we see patients with heart failure, what we see and what drives the disease is a neurohormonal imbalance. There’s an increase in bad factors, and there’s a decrease in some of the good, or adaptive factors. In the body, the heart and in circulation, normally there’s a balance. In people with heart failure, this balance is disturbed.

For the last 25-30 years, the way we treated heart failure was, we tried to decrease the bad factors, but did nothing to increase the good ones.

This drug decreases the bad factors while increasing the good factors at the same time.

This is why the study is “one of the most important cardiology advances of the last decade,” said David Epstein, the division head at Novartis. The company says heart failure costs the world economy $108 billion per year, with hospitalizations making up 60 to 70 percent of treatment costs.

A safety analysis in the randomized, double-blind study found the side effects were manageable, and that “fewer patients on LCZ696 discontinued study medication for any adverse event compared to those on enalapril.” The LCZ696 group had more hypotension and non-serious angioedema, Novartis said, but less kidney dysfunction, hyperkalemia and cough than the control group.

As an aside, it’ll be interesting to check Novartis’ stock price when trading opens next week. This one’s a big one. While Packer, a researcher, wouldn’t comment on the market potential for the drug, he did offer some levity:

“Most of the time when I try to make predictions about the market, you’d be much better served to do the opposite of what I just said,” he said. “I do think it’ll have a major impact on clinical practice.”

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