Amgen
cholesterol drug succeeds in cutting serious heart
problems: study
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[February 03, 2017]
By Bill Berkrot
(Reuters) - Amgen Inc said its potent
cholesterol fighter Repatha significantly reduced the risk of heart
attacks, strokes and death in patients with heart disease, according to
initial results of a large, eagerly-anticipated trial released on
Thursday. The data should pave the way for greater acceptance by health
insurers and pharmacy benefit managers, who have been rejecting about 75
percent of prescriptions written for the expensive medicine despite
multiple appeals by physicians.
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No new safety problems cropped up in the 27,500 patient study called
Fourier, Amgen said. It also said Repatha's effect on mental
function was similar to placebo, likely alleviating concerns that it
might impair cognition in some patients.
The trial was widely expected to be positive, especially after a
smaller study presented in November showed Repatha therapy led to
regression of artery-clogging plaque, an underlying cause of heart
disease.
"These results show unequivocally the connection between lowering
LDL cholesterol with Repatha and cardiovascular risk reduction, even
in a population already treated with optimized statin therapy,"
Amgen research chief Sean Harper said in a statement.

Details on the magnitude of benefit will be revealed in mid-March at
the American College of Cardiology meeting in Washington, D.C.
Industry analysts have been looking for a 15 percent to 20 percent
reduction of major adverse heart events.
Repatha, with a list price of more than $14,000 a year, was approved
based on its ability to dramatically lower "bad" LDL cholesterol in
patients who require more intensive therapy on top of widely-used
statins, such as Lipitor, or who are unable to tolerate statins.
But those who control budgets wanted concrete proof that the drug
could actually reduce the risk of heart attacks and death before
making it easier for patients to get the medicine.
Repatha and a rival drug from Regeneron Corp and Sanofi have had
endured anemic sales as a result.
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Amgen reported just $40 million in third-quarter sales. The company
said Repatha would be well on its way to becoming a $1 billion
seller if all prescriptions written had been filled.
The primary and secondary goals of the study are composites of
several adverse outcomes. At the heart meeting in March, researchers
will also provide details on risk reduction for each of the
components, such as non-fatal heart attack, non-fatal stroke, and
heart-related death.
The primary goal also included need for a new artery-clearing
procedure and hospitalization for angina.
(Reporting by Bill Berkrot; Editing by Alan Crosby)
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