The Food and Drug Administration on Wednesday approved a drug to treat chronic heart failure that may help keep patients out of the hospital.
The drug, which Amgen will sell under the name Corlanor, works by slowing the heart rate, which helps relieve stress on the organ. Amgen licensed the American rights to the drug, known generically as ivabradine, from the French company Servier, which has been selling it in Europe for about a decade.
Many Wall Street analysts and heart failure specialists are lukewarm about the drug, which has had mixed results in clinical trials. They are more excited about a heart failure drug from Novartis, called LCZ696, which could be approved by August.
Amgen's drug will be for "a niche of patients, potentially small, compared to a full cohort of patients who will be immediate candidates for LCZ696," Dr. Clyde W. Yancy, chief of the cardiology division at the Feinberg School of Medicine at Northwestern University, wrote in an email.
Still, the approval moves Amgen into the cardiology drug business, preparing it for the expected approval this summer of a much more important cardiovascular drug — a powerful cholesterol fighter called evolocumab.
More than five million Americans suffer from heart failure, in which the heart does not pump blood adequately, a condition that can result from a heart attack or other causes. Heart failure is a leading cause of hospitalizations.
People with heart failure now take various drugs, including beta blockers, which work partly by slowing down the heart beat. Corlanor is approved for patients whose resting heart rate is still above 70 beats a minute — considered high enough to strain the heart — despite taking the highest dose of beta blockers they can tolerate. Dr. Sean E. Harper, executive vice president for research and development at Amgen, said about one million Americans fit that description.
Amgen will charge $375 a month, or about $4,500 a year, for Corlanor, which could be a challenge because most other drugs used for heart failure are relatively low-cost generics. But Dr. Harper said the drug could save the health care system money by reducing hospitalizations.
"It's an unusual circumstance where the impact of the product is so tangibly calculable," he said.
He said Corlanor, a pill taken twice a day, represents the first new type of drug for heart failure that has been approved in about a decade. The drug works by inhibiting what is known as the "funny current" in the heart's natural pacemaker.
Amgen won approval based on a trial sponsored by Servier that involved more than 6,500 patients with moderate to severe heart failure and heart rates over 70 beats a minute. They were randomly assigned to take either ivabradine or a placebo, in addition to their existing medications.
After nearly two years, 16 percent of patients receiving ivabradine were hospitalized for worsening heart failure compared with 21 percent of those getting the placebo. That represented a reduction in risk of 26 percent by a measure known as the hazard ratio. The drug also reduced deaths from heart failure but not deaths from all cardiovascular causes, according to the results published in The Lancet in 2010.
Dr. Yancy said the results of the trial, which was conducted from 2006 to 2009 outside the United States, might not fully apply to American patients treated with the most modern methods.
There have been other studies, albeit in different patient populations, in which the drug did not work as well. The European Medicines Agency said last year that in certain patients with angina, which is chest pain from insufficient blood flow to the heart, the drug might actually increase the risk of heart attacks and deaths from cardiovascular causes. The drug can also cause heart rates to drop dangerously low in some patients.
Anda sedang membaca artikel tentang
F.D.A. Approves Amgen Drug to Treat Heart Failure
Dengan url
http://healtybodyguard.blogspot.com/2015/04/fda-approves-amgen-drug-to-treat-heart.html
Anda boleh menyebar luaskannya atau mengcopy paste-nya
F.D.A. Approves Amgen Drug to Treat Heart Failure
namun jangan lupa untuk meletakkan link
F.D.A. Approves Amgen Drug to Treat Heart Failure
sebagai sumbernya
0 komentar:
Posting Komentar