Investigational Heart Failure Drug LCZ696 Gets Glowing Reviews

Novartis plans to soon file a new drug application with the US Food and Drug Administration (FDA) for its investigational heart failure drug LCZ696.

A report showing the drug works better than enalapril to prevent adverse cardiac events was released at the European Society of Cardiology Congress in Barcelona, Spain Aug. 30 and published online in the New England Journal of Medicine (NEJM).

The experimental drug from Novartis reduced study participants’ chances of being hospitalized or dying from heart failure by 20% compared to patients in the study who got enalapril.

According to a Novartis spokeswoman the FDA application will be filed by the end of 2014 and a second request for approval will be filed with European regulators in early 2015.

In the NEJM article reporting on a study known as PARADIGM-HF, lead researcher John McMurray, MD reported that the trial of the drug, an angiotensin receptor-neprilysin inhibitor was halted early because of “an overwhelming benefit with LCZ696.”

The study name is taken from “Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor with ACE Inheritor to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial.

In an accompanying NEJM editorial, Mariell Jessup, MD, said the drug “may well represent a new threshold of hope for patients with heart failure.” That includes greater long-term survival, Jessup wrote. She is a professor of medicine at the Hospital of the University of Pennsylvania in Philadelphia, PA.

There were 8,442 patients in the study, all of whom had class II, III, or IV heart failure and an ejection fraction of 40% or less.

They got either the investigational drug (at a dose of 200 mg twice a day) or enalapril (10 mg twice a day) in addition to standard therapy.

The study drug “was more effective in reducing the risk of death from cardiovascular causes or hospitalization for heart failure than was ACE inhibition with enalapril” the authors wrote. Sold by Merck as Vasotec and Vaseretic, it brought in $192 million in 2012, according to the company’s filings with the US Securities and Exchange Commission. In 2010, the year Merck lost patent protection and the drug became available in generic form, sales were $255 million.

The FDA has already granted LCZ696 fast track designation. Novartis paid for the study.