Federal regulators approved the first of a powerful new class of
cholesterol-lowering medicines, developed by Regeneron
Pharmaceuticals Inc. and Sanofi SA.
The drug, called Praluent, provides a new option for several
million high-risk heart patients who can't get their cholesterol to
desirable levels with statin drugs, but it promises to escalate a
growing chorus of concern over high drug prices.
The price for Praluent wasn't immediately announced, but
analysts have speculated it will be in a range of $7,000 to
$12,000, which would make it by far the most costly medicine aimed
at a common condition like heart disease. By contrast, statins,
which are available in generic versions and remain the mainstay
drug option for cholesterol reduction, can be purchased for just a
few dollars a month.
The company believes "we've come up with a price that provides
value to the health-care system," said Leonard Schleifer,
Regeneron's president and chief executive officer.
Praluent is the first approval in the U.S. of a class of drugs
known as PCSK9 inhibitors. Amgen's PCSK9 drug Repatha was approved
earlier this week in Europe and is expected to get the nod from the
U.S. Food and Drug Administration by Aug. 27. The drugs work by
blocking the PCSK9 protein, which interferes with the body's
ability to clear artery-damaging cholesterol from the blood.
In clinical trials, the drug has been shown to reduce LDL
cholesterol by 50% to 70% beyond that achieved with statins
alone.
According to the label, Praluent is approved for patients with
inherited very high cholesterol, a condition known as heterozygous
familial hypercholesterolemia, or with established clinical
cardiovascular and who can't achieve desired LDL levels on statins
alone.
The new drugs represent the most significant advance against
cholesterol since the introduction of statins 28 years ago.
Statins, such as the blockbuster Lipitor, are taken by some 40
million Americans and in addition to a healthy diet and exercise
remain the mainstay strategy to lower LDL cholesterol, the chief
culprit in the accumulation of deposits in the coronary arteries
that lead to heart attacks.
Whether PCSK9 inhibitors can achieve a commensurate reduction in
heart attacks and other consequences of heart disease while
maintaining their currently safe side-effect profile won't be known
until results of larger, long-term studies are reported, which are
expected by 2017.
Write to Ron Winslow at ron.winslow@wsj.com
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