UPDATE 3-US advisers back wider use of Allergan weight band

* Panel votes 8-2 that benefits outweigh risks

* FDA usually follows panel recommendations

* Wider approval could boost sales

* Allergan shares up 3.2 pct in after-hours trade
(Adds further panel member comments; updates shares; edits)

By Lisa Richwine

GAITHERSBURG, Md., Dec 3 (BestGrowthStock) – Allergan Inc’s (AGN.N: )
stomach band won support from U.S. advisers for implanting in
people who are less obese than those now approved as candidates
for the weight-loss surgery.

A panel of Food and Drug Administration advisers voted 8-2
on Friday that the benefits of the Lap-Band outweighed the
risks for patients with lower body mass indexes who are still
categorized as obese.

Wider approval could make millions more people eligible for
the Lap-Band and boost sales from the $182 million seen in the
first three quarters of 2010.

Shares of Allergan, the maker of Botox, breast implants and
other cosmetic products, were up 3.2 percent to $71 in
after-hours trade on Friday from their $68.80 close on the New
York Stock Exchange.

Panel members voiced concern that Allergan did not study
patients long enough to know the full risks of a lifetime
implant, but most welcomed another weight-loss option in a
nation where two out of three people are overweight or obese.

“We’re losing this battle,” said Dr. Jeffrey Zitsman, a
panelist and director of the Center for Adolescent Bariatric
Surgery at the Morgan Stanley Children’s Hospital of New York.

“Ideally … we’d be able to change behavior, but we need
tools to address this,” Zitsman added.

The FDA will make a final decision on the wider use. The
agency typically follows the advice of its advisory panels.


The device is a band placed around the upper part of the
stomach to create a small pouch and limit food intake.

Allergan wants to promote the device for adults with a body
mass index of 35 or higher, or at least 30 plus one
weight-related health problem such as diabetes or high blood
pressure. A person 6 feet (1.8 meters) tall would need to weigh
about 225 pounds (102 kilograms) to have a BMI of at least 30.

The Lap-Band is already cleared for adults with a BMI of at
least 40, or at least 35 plus one other health problem. About
15 million Americans are candidates under the currently
approved definition and about 27 million more fit under the
broader group, Allergan said.

Not everyone would choose surgery if the eligible pool
expands. While millions qualify now, the worldwide number of
Lap-Band implants is around 600,000.

The surgery costs between $12,000 and $20,000, and many
patients have to pay part or all of it with their own funds.
Johnson & Johnson (JNJ.N: ) sells a rival device called Realize.

Collins Stewart analyst Louise Chen said she conservatively
estimates Lap-Band sales could rise to $390 million annually by
2016. Allergan’s revenues totaled $4.5 billion in 2009.

Obesity raises the risk of heart disease, diabetes, and
other problems. Efforts to fight fat with a pill have produced
only limited success.

Separately on Friday, FDA staff said an experimental diet
pill from Orexigen Therapeutics (OREX.O: ), the third weight-loss
drug under review this year, was effective for some patients
but raised concern about its risks. An advisory panel will vote
on that drug on Tuesday. [ID:nN0340431]

For the Lap-Band, Allergan studied 149 patients in the less
obese group. Nearly 81 percent of them had lost at least 30
percent of their weight at one year, and two-thirds were no
longer considered obese, the company said.

No unexpected complications were reported through one year.
About 2 percent of device-related problems were severe, FDA
staff said. Seven patients required a new operation for reasons
such as band erosion or slippage. No patients died during the
study, although death is a risk with the surgery.

Several panelists said the company needed to study a larger
number of patients for at least five years to evaluate
long-term risks, particularly repeat operation rates, and how
long weight loss lasts.

“I don’t think 149 patients with one- and two-year
follow-up is good for generalizing long-term results,” said Dr.
Jon Gould, a panel member and bariatric surgeon at the
University of Wisconsin.
(Reporting by Lisa Richwine; Editing by Dave Zimmerman and Tim

UPDATE 3-US advisers back wider use of Allergan weight band