WASHINGTON (Reuters) – Amylin Pharmaceuticals won U.S. approval
on Friday for its "lw_1327701069_6">Bydureon "lw_1327701069_4">diabetes drug, a long-awaited victory
for the company's most promising product.

After two delays, the "lw_1327701069_1">Food and Drug Administration approved
once-weekly injectable Bydureon for treating adults with
Type 2
diabetes, the kind linked to poor diet and lack of
exercise. Bydureon is a longer-acting form of "yshortcuts" id="lw_1327701069_2">Amylin's older Byetta
treatment.

Shares of Amylin and partner "lw_1327701069_5">Alkermes, which provided some
technology for the medicine, were halted ahead of the
announcement of the FDA's decision.

More than 300 million people worldwide suffer from diabetes,
including nearly 26 million Americans. They run a high risk of
heart disease, stroke, kidney failure, blindness and limb loss.

Bydureon is seen as Amylin's most important new drug, and
critical to its future earnings growth, with analysts
estimating peak sales of close to $1 billion.

But after repeated delays in gaining approval in the United
States, the medicine faces a daunting competitive landscape.

Novo Nordisk's Victoza, another injectable "yshortcuts" id="lw_1327701069_3">diabetes medicine, has
had almost two extra years to gain traction with patients and
doctors. The delays have also given time for potential rivals
from GlaxoSmithKline Plc and Sanofi to catch up.

The FDA had rejected Bydureon twice before, most recently in
October 2010, asking for more data on potential side effects to
the heart. A trial of Bydureon in July found no link between
the drug and changes in heart rhythms, the company said.

However, as a condition of approval, the FDA on Friday said
Amylin must conduct another long-term clinical trial by 2018 to
study heart-related side effects from Bydureon.

WITHOUT LILLY

Taken once a week, Bydureon has been viewed as crucial to
sustaining the franchise started by the twice-daily Byetta.

Investors are closely watching whether Amylin will be able to
pull off a successful launch without the help of long-time
partner Eli Lilly & Co after the two companies broke off
their diabetes partnership in November. Alkermes would also get
royalties from the sales of Bydureon.

Amylin said Bydureon would be available in U.S. pharmacies
starting in February.

Victoza, which is injected daily, proved superior to Bydureon
in controlling blood sugar levels, trial results published last
March showed.

But Bydureon may get a boost because of its more convenient
dosing.

Analysts at Deutsche Bank said they expect peak Bydureon sales
of $1.5 billion, above market forecasts of $940 million by
2016, because of its convenience compared with Victoza.

Bydureon, Byetta and Victoza belong to the new GLP-1 class of
therapies that stimulate insulin production when blood sugar
levels become too high. They can also prompt weight loss, a
benefit because obesity is a leading cause of diabetes.

European regulators approved Bydureon as a treatment for Type 2
diabetes in April 2011.

(Reporting by Anna Yukhananov, additional reporting by Deena
Beasley in Los Angeles; Editing by Tim Dobbyn and Stever
Orlofsky)