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 The FDA will decide by Dec. 2 whether to allow Amgen to include data
from a major clinical trial that showed Repatha significantly cut
the risk of heart attack, stroke and death in addition to
dramatically lowering bad LDL cholesterol, the company said.
Amgen, which cannot promote the heart safety data until it is
officially included in the prescribing information, sees the label
update as critical to unlocking the value of a medicine seen as
having multibillion-dollar sales potential.
"We look forward to working with the FDA to update the label for
Repatha, enabling us to more broadly educate physicians and patients
of the proven impact of Repatha to reduce cardiovascular events,"
Amgen research and development chief Sean Harper said in a
statement.
Repatha has had improving but anemic sales since its approval nearly
two years ago on the basis of its LDL-lowering prowess, with
second-quarter sales of just $83 million.
Insurers and pharmacy benefit managers have put up onerous
roadblocks to patient access for the drug, with some 75 percent of
prescriptions written being denied.
Amgen has said after discounts and rebates Repatha's net price falls
between $7,700 and $11,200 a year.
Clinical evidence that the injectable biotech drug does more than
just lower LDL was considered necessary for payers to open their
pocket books and start authorizing wider use.
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In the study of more than 27,000 patients called Fourier that was
released in March, Repatha cut the combined risk of heart attacks,
strokes and heart-related death by 20 percent compared with a
placebo in high-risk patients already on high doses of
cholesterol-lowering statins, such as Pfizer Inc's Lipitor.
In the second year of the study, the benefits were more pronounced,
with a combined heart attack and stroke risk reduction of 33
percent.
Repatha and Praluent, sold by Regeneron Pharmaceuticals Inc and
Sanofi, belong to a new class of medicines called PCSK9 inhibitors
that block a protein that stops LDL from being removed from the
blood.
(Reporting by Bill Berkrot in New York; Editing by Lisa Shumaker)
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