FDA approves Amylin to make first weekly diabetes drug in West Chester

The weekly injections will be produced at Amylin Pharmaceuticals’ manufacturing facility at 8814 Trade Port Drive.

On Friday, the U.S. Food and Drug Administration approved Amylin’s drug Bydureon for sale in the U.S., according to the company. Amylin said the product will be launched in pharmacies nationwide in February.

Amylin started operating its local manufacturing plant in 2009. U.S. FDA approval was delayed more than a year. During that time, Amylin made its initial launch of Bydureon in Europe last year. Approvals are also pending in Japan, according to the company.

The West Chester Twp. facility has about 300 employees.

“Significantly, it’s a big deal now because it’s the first of the long-acting diabetes drugs to be approved,” said Tony Dennis, president and chief executive officer of BioOhio, a nonprofit focused on building the state’s bioscience industry. “Now it’ll be a matter of how well it does in the marketplace.”

The U.S. regulatory approval doesn’t mean Amylin will go on a hiring spree. Because Amylin had regulatory approval from the European Commission, employees are already manufacturing the drug. Employees have been able to increase production in anticipation of U.S. approval, making some parts of the drug and holding it for final packaging, said Alice Izzo, spokeswoman for Amylin.

With U.S. approval, Amylin employees can finish the manufacturing and packaging for the U.S. market, Izzo said. She didn’t disclose how much production volumes will increase.

As demand for Bydureon increases, Amylin will increase hiring, she said.

“We did everything we could while we were waiting for those final approvals,” she said.

Amylin is a San Diego, Calif.-based pharmaceutical company focused on diabetes and other metabolic issues. The company was welcomed with tax incentives from the township and funding from Ohio Third Frontier.

Contact this reporter at (513) 705-2551 or clevingston@coxohio.com.

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