By Lisa Beilfuss
The U.S. Food and Drug Administration on Wednesday approved
Amgen Inc.'s heart-failure treatment Corlanor, which had been
designated for priority review in August.
The drug is an oral medication intended to regulate heart rate
and reduce the risk of hospitalization for worsening heart failure
in patients with stable, chronic heart failure caused by a
poorly-contracting lower-left part of the heart.
Amgen said Corlanor is the first new chronic heart-failure
medicine approved by the FDA in nearly a decade.
According to the company, heart failure costs an estimated $31
billion in the U.S. each year, with the majority of the cost
related to hospitalizations. The condition affects approximately
5.7 million people in the U.S., about half of whom have reduced
left ventricular function, the FDA noted in a statement.
In a 6,500-patient study, Corlanor, on top of standard
medications for heart failure, reduced the combination of death
from cardiovascular disease and hospitalization for heart failure
by 25%, Amgen said. Most of the benefit came from fewer hospital
admissions.
"If you're a heart-failure doctor, you're desperate for
something more to do for these patients," said Sean Harper, Amgen's
head of research and development.
The FDA granted fast-track status for the drug last April and
then assigned the priority review designation about four months
later. Priority review is granted to drugs intended to treat
serious conditions that, if approved, would demonstrate significant
improvements in the safety or effectiveness of treatment, diagnosis
or prevention when compared with standard applications.
The European Medicines Agency approved the drug in 2005 to treat
stable angina and then approved it in 2012 to treat chronic heart
failure.
Amgen shares rose 1.3% to $167.63 in after-hours trading, adding
to the 4% year-to-date gain through Wednesday's close.
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