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 Last month the FDA approved a similar drug from Regeneron
Pharmaceuticals Inc and Sanofi SA. The drugs belong to a potent new
class of injectable LDL-lowering drugs known as PCSK9 inhibitors.
Repatha was approved to treat patients with heterozygous familial
hypercholesterolemia (HeFH) and patients with the rarer homozygous (HoFH)
form of the disease. It was also approved for patients with
cardiovascular disease including heart attack or stroke, who require
additional cholesterol lowering.
Amgen's shares rose 0.5 percent to $156.50 in extended trading.
The scope of the approval was similar to the approval given to the
Regeneron drug, Praluent, which was approved for patients with
cardiovascular disease and those with HeFH.
The drugs are expected to generate more than $2 billion a year each
in sales by 2020, according to Thomson Reuters data.
"The back-to-back approvals for Praluent and Repatha should allow
natural market competition to influence the immediate cost for the
PCSK9 inhibitors," Steve Miller, chief medical officer at pharmacy
benefit manager Express Scripts Holding Co, said in an emailed
statement.
"And we plan to leverage this competition to achieve the greatest
possible discounts for our clients and patients.”
Praluent is given every other week by injection in doses of 75 mg or
150 mg. Both doses of the drug will be priced wholesale at $1,120
for a 28-day supply, or roughly $14,560 a year.
After rebates, analysts expect the drug to cost about $12,400 a
year.
Repatha is given as a 140 mg injection every other week or as a
monthly injection of 420 mg. Amgen said the wholesale cost of the
drug will be $14,100 a year for the every other week injection. The
product will be available next week.
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Amgen said it plans to make the monthly dosing option available next
year.
The drugs are more potent than traditional cholesterol-lowering
statin drugs, such as Pfizer Inc's Lipitor. But it is not yet known
whether their cholesterol-lowering power will translate into a
reduced number of heart attacks.
The companies are conducting so-called cardiovascular outcomes
trials to determine whether their ability to dramatically lower bad
LDL cholesterol will lead to fewer heart attacks, strokes and
deaths.
America's Health Insurance Plans, the industry trade group, has
protested the high price of Praluent, saying it has concerns about
the health system's ability to sustain the long-term costs.
(Reporting by Toni Clarke, additional reporting by Bill Berkrot in
New York and Deena Beasley in Los Angeles; Editing by Sandra Maler,
Dan Grebler and Alan Crosby)
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