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FDA seeks data on delivery method for Amylin drug
June 5, 2012 / 10:32 PM / 5 years ago

FDA seeks data on delivery method for Amylin drug

(Reuters) - Amylin Pharmaceuticals Inc said U.S. health regulators have requested data on a new delivery system for its recently approved long-acting diabetes drug Bydureon.

Amylin, which is seeking approval for the new pen-delivery system as an alternative to the current needle injections, said in a regulatory filing on Tuesday that it received comments from the Food and Drug Administration on its application, including a request for “incremental device-related data.”

The biotech company, which is taking bids from potential buyers seeking to acquire Amylin and its diabetes franchise, said it would respond to the FDA in a timely fashion.

Amylin also said it hopes to have the Bydureon pen-delivery system available to patients in 2013.

In January - after lengthy delays - the FDA approved Bydureon, a once weekly version of Amylin’s older Type 2 diabetes drug Byetta, known chemically as exenatide.

Patients currently have to fill their own syringe before injecting Bydureon.

The pen-delivery system has the drug pre-filled, making it potentially more convenient for diabetics.

Amylin’s stock fell 1.1 percent in extended-hours trading to $27.05 from its Nasdaq close at $27.35. During the regular session, the stock gained 72 cents, or 2.7 percent.

Reporting by Bill Berkrot; Editing by Gary Hill and Jan Paschal

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