The Food and Drug Administration Wednesday
approved a new weight-loss drug made by Arena Pharmaceuticals Inc., ARNA
+28.70%marking the first new drug treatment in more than a decade.
The drug, lorcaserin, will be marketed
under the brand name Belviq and distributed by Eisai Co. Ltd. 4523.TO +0.90%The
approval comes more than a month after an FDA advisory panel voted to back the
use of the product. The approval of Belviq and other anti-obesity drugs has
been held up for several years amid potential safety concerns that included
heart-valve disease and in some cases cancer.
Another small drug developer, Vivus Inc.,
VVUS +7.35%is hoping to win FDA approval for its weight-loss drug Qnexa by
mid-July.
The FDA said Belviq is meant to be used as
part of an overall weight-management plan that includes a reduced calorie diet
and exercise. More than two-thirds of Americans are overweight and one-third
are considered obese. This raises the risk of developing heart disease,
diabetes and cancer.
Shares of Arena, which had been halted
pending the announcement, surged 29%, or $2.54, to $11.39 at 4 p.m. on the
Nasdaq Stock Market following the FDA's decision. The drug would be the first
commercial product for the San Diego company, which was founded in 1997 and has
been unprofitable.
However, Belviq won't immediately be
available for sale. The drug has to go through a four-to-six month process at
the Drug Enforcement Administration for a scheduling classification used for
drugs that have a likelihood or potential of being abused. Once that process is
over, Eisai will announce pricing and when the drug will be available.
Analysts have been cautious in their
estimates for Belviq's annual sales, and they generally expect Qnexa, if
approved, to grab a larger share of the market. However, the potential market
size is worth billions of dollars, and Belviq is expected to be used alone and
in combination with drugs like Qnexa, assuming they are approved. Studies of
Qnexa showed many patients could lose 10% or more of their body weight.
The FDA said clinical studies of Belviq
showed it was associated with an average weight loss of 3% to 3.7% lasting up
to one year, compared with patients receiving a placebo medication. However,
another study looking at patients with diabetes showed many of them were able
to lose at least 5% of their body weight.
The drug is designed to activate a receptor
called serotonin 2c in the brain, which may help a person eat less and feel
full after eating.
The FDA said Belviq should be stopped in
patients who fail to lose 5% of their body weight after 12 weeks of treatment
because they are unlikely to "achieve clinically meaningful weight
loss." The drug was approved to treat people who are obese, which is
defined as a body mass index of 30 or higher, and people who are overweight,
with a BMI of 27 or higher, and who also have at least one weight-related
problem like high-blood pressure, high cholesterol or diabetes. BMI is a measure
of body fat that uses height and weight in the calculation.
The development of obesity compounds has
been a tough area for companies since the fen-phen drug combination was taken
off the U.S. market in 1997, after one of the medication's components was
linked to heart-valve damage. Abbott Laboratories ABT +0.83%removed its
weight-loss drug Meridia from the U.S. market in 2010 amid concerns about the
drug's risk of side effects like heart attack and stroke.
Arena will be required to conduct a long-term
cardiovascular-outcomes study to access the risks of heart attacks and strokes,
in addition to five other post-marketing studies, the FDA said.
Earlier this year an FDA advisory panel
voted to back Qnexa, but in April the FDA delayed a decision until July 17. The
agency is requiring another antiobesity drug, Contrave, from Orexigen
Therapeutics Inc., OREX +20.29%to undergo testing in a cardiovascular-outcomes
study before the FDA will consider approving the drug. Orexigen said earlier
this month that it has started enrolling patients in that study
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