FDA Approves Amgen's Cholesterol-Lowering Drug Repatha -- Update
August 27 2015 - 08:00PM
Dow Jones News
By Jonathan D. Rockoff
The Food and Drug Administration approved Amgen Inc.'s
cholesterol-lowering drug on Thursday, teeing up a rivalry with a
similar treatment that was approved just weeks earlier.
The Amgen therapy, Repatha, belongs to a powerful new drug class
that promises help for patients who have struggled to control their
cholesterol using older statin medicines. In July, the FDA approved
the first drug of this new class, Praluent, from Sanofi SA and
Regeneron Pharmaceuticals Inc.
Doctors and patients have been looking forward to these new
cholesterol-lowering agents, which are injections either monthly or
every two weeks. Some 11 million people in the U.S. can't lower
their so-called bad cholesterol, LDLs, to healthy levels using
statin pills like Lipitor and Crestor, according to Amgen.
"Many patients who are in a state where they cannot get to an
acceptable LDL level will benefit," Amgen's research and
development chief Sean Harper said in an interview.
Yet health insurers and drug-benefit managers have expressed
concerns about the new drugs' cost. Amgen said it is pricing
Repatha at $14,100 a year, while Praluent comes in at $14,600.
Analysts say the new drug class could eventually reach yearly sales
of $10 billion world-wide.
As it did with Praluent, the FDA approved Repatha to be taken
with statin drugs, for patients with a hereditary condition called
familial hypercholesterolemia or with coronary artery disease that
requires additional lowering of cholesterol.
The rivalry between the new agents gives the insurers and
drug-benefit managers a chance to negotiate discounts. These
payers, like Express Scripts Holding Co., have held off on
finalizing decisions about coverage of Praluent because they
expected Repatha to be approved soon after.
"We plan to leverage this competition to achieve the best
possible price for the patients and payers we represent," an
Express Scripts spokesman said.
Such competition, so early in the life of a new drug class, used
to be unusual. Drug companies that were first to bring a new drug
to market could gain a sizable advantage, said Pratap Khedkar, who
leads the pharmaceutical practice at sales and marketing firm ZS
Associates.
Yet more recently, rival skin-cancer immunotherapies Keytruda
and Opdivo as well as hepatitis C drugs Harvoni and Viekira Pak
were approved within a few months of each other. Esbriet and Ofev,
competing treatments for a lung-scarring condition, were cleared on
the same day last October.
"The order of entry advantage, which used to be significant, is
less than it used to be and will probably diminish" further, Mr.
Khedkar said.
He suspects the time gap between product approvals is closing
because companies are pursuing the same drug targets, often
identified by private researchers exploring the molecular roots of
disease and then publishing their work for any company to use.
Both Repatha and Praluent work by targeting a protein, called
PCSK9, that interferes with the liver's ability to clear
cholesterol.
Dr. Harper said the focus on the pricing of the drugs overlooks
their potential value preventing life-threatening heart attacks and
strokes and avoiding the resulting treatment costs. Studies are
under way to establish whether each of the drugs reduce the risk of
such events, the goal of cutting cholesterol to desired levels.
More competition could emerge over the next few years from
companies like Pfizer Inc. that are developing their own versions
of a PCSK9 agent. In addition, companies including Eli Lilly &
Co. have been working on a separate new class of
cholesterol-fighting agents known as CETP inhibitors.
For Amgen, Repatha sales could help offset competition that is
looming for some of its aging biotech drugs. Last month, a U.S.
appeals court ruled that Novartis AG could begin sales on Sept. 2
of Zarxio, a lower-priced version of Amgen's Neupogen cancer
supportive-care therapy.
Also on Thursday, Amgen said it has asked the court to block
Zarxio sales from starting while the judges consider rehearing the
case. A spokesman for Novartis said it is aware of the legal
request and is looking forward "to launching Zarxio in the U.S.
after Sept. 2."
Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
August 27, 2015 19:45 ET (23:45 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
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