New Novartis Drug Effective in Treating Heart FailurePosted on September 11, 2014 by ECR Louisville in Blog, Caregiver Education
An experimental drug has shown a striking efficacy in prolonging the lives of people with heart failure and could replace what has been the bedrock treatment for more than 20 years, researchers said on Saturday.
The drug, which is being developed by the Swiss company Novartis, reduced both the risk of dying from cardiovascular causes and the risk of being hospitalized for worsening heart failure by about 20 percent in a large clinical trial.
“I think that when physicians see these data, they will find it compelling, and what we will see is a paradigm shift,” 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.
The results are being presented at the European Society of Cardiology congress in Barcelona, Spain, this weekend and were published on Saturday by The New England Journal of Medicine.
Heart failure is a disease in which the heart cannot pump enough blood to the body’s organs, resulting in shortness of breath, fatigue and retention of fluids.
Five million to six million Americans, and an estimated 26 million people globally, have heart failure, and it is the leading cause of hospitalization in the United States and Europe, according to a recent paper in the Journal of the American College of Cardiology.
Some doctors not involved in the study agreed that the results were compelling.
“They are not just positive, they are remarkably positive and positive in every dimension,” said Dr. Clyde W. Yancy, chief of the cardiology division at the Northwestern University Feinberg School of Medicine. “Patients with heart failure are eager, if not desperate, to have better options.”
Novartis executives say the company will file for approval of the drug, known by the code name LCZ696, in the United States by the end of the year and in Europe in the first quarter of 2015. That means the drug could get to patients as early as next year.
Novartis announced in March that the study was being ended early because the drug had been better than the comparator drug. But until Saturday, it was not known exactly how much better.
Some Wall Street analysts predict the drug, a tablet taken twice a day, will achieve billions of dollars in annual sales. Seamus Fernandez, an analyst at Leerink Partners, said on Saturday that the results were “near best case” and “could result in faster uptake, higher penetration and more robust branded pricing.”
As a proprietary drug, LCZ696 is likely to be expensive. Tim Anderson, an analyst at Sanford C. Bernstein & Company, estimates that it might cost $7 a day in the United States, or about $2,500 a year. Existing drugs are generic, costing as little as $4 a month, so insurers might balk at paying for the new drug.
David Epstein, the head of Novartis’s pharmaceutical division, said the company could make a good case to payers. “It’s very rare that a drug like this comes along,” he said, “one where people live longer, have less hospitalizations and other costs and feel better.”
The patients were followed for a median of 27 months. By that point, 21.8 percent of those who received LCZ696 had died from a cardiovascular cause or had been hospitalized for worsening heart failure. That figure was 26.5 percent for those receiving enalapril. That represents a 20 percent relative reduction in risk using a statistical measure called the hazard ratio.
The reductions in risk for both cardiovascular death alone and hospitalization alone were also about 20 percent. About 32 patients had to be treated with LCZ696 to prevent one death from cardiovascular causes.
LCZ696 was relatively well tolerated, though patients who clearly could not tolerate the specified doses of either LCZ696 or enalapril were eliminated from the trial in advance. LCZ696 caused more hypotension, or too-low blood pressure, but fewer kidney problems than enalapril.
Dr. Marc A. Pfeffer, a cardiologist at Brigham & Women’s Hospital who was not involved in the trial, said it was impressive that LCZ696 could improve on existing therapy “because the bar really is high.” But Dr. Alfred Bove, a professor emeritus at Temple University, said that while the relative risk reduction was large, the absolute difference was only about 3 percentage points — 17 percent of patients getting LCZ696 died of any cause compared with 19.8 percent in the control arm.
Dr. Yancy of Northwestern said one caution was that only about 5 percent of patients in the study were of African descent, even though in the United States blacks suffer disproportionately from heart failure.
He said that about a decade ago, a somewhat similar drug never made it to market, because it caused a serious side effect called angioedema, mainly in African-Americans. He said, however, that LCZ696 did not seem to pose that risk, though more observation was needed.
LCZ696 is a combination of two drugs. One is valsartan, the blockbuster heart drug that Novartis sells as Diovan. The other component inhibits the enzyme neprilysin, a new mechanism of action for a heart failure drug.
Novartis could use a hit to make up for declining sales of Diovan, which has lost patent protection. A success with LCZ696, which is for chronic heart failure, would help offset the company’s recent inability to win regulatory approval for serelaxin, for acute heart failure.
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The New York Times