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UPDATE 1-Weather delays US FDA action on long-acting Byetta
February 25, 2010 / 1:50 PM / 8 years ago

UPDATE 1-Weather delays US FDA action on long-acting Byetta

* Weather pushes back FDA action date 5 days

* FDA sets new action date of March 12

NEW YORK, Feb 25 (Reuters) - Due to weather-related delays, U.S. regulators will need an additional five days to act on a marketing application filed by Amylin Pharmaceuticals Inc and Eli Lilly and Co for a once-weekly form of their diabetes drug Byetta, the drugmakers said.

Amylin AMLN.O and Lilly (LLY.N) on Thursday said the U.S. Food and Drug Administration has set a new action date of March 12 for the injectable product. Investors are hoping its far greater convenience than the currently available twice-daily Byetta will greatly boost sales of the franchise, and profits for the two companies.

The drug, whose chemical name is exenatide and has annual sales of about $700 million, is used to treat type II diabetes -- the more common form of diabetes which is closely linked to obesity.

In clinical trials, patients treated with the once-weekly formulation showed a statistically superior reduction in blood sugar than those taking standard Byetta.

Byetta is also widely used because it leads to weight reductions, in contrast to many other diabetes treatments that tend to cause weight gains.

But it has been strapped with its own safety concerns, including links to pancreatitis and kidney function problems. (Reporting by Ransdell Pierson; Editing by Lisa Von Ahn)

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