FDA asks Amylin and partners for risk plan, manufacturing information on diabetes drug

FDA asks for risk plan info on diabetes drug

SAN DIEGO — Amylin Pharmaceuticals Inc. said Monday it received a Food and Drug Administration request for information on manufacturing and a risk mitigation plan for a potential once-weekly diabetes treatment.

Amylin, along with partners Eli Lilly & Co. and Alkermes Inc., are not being asked to conduct additional studies on the much anticipated drug. The FDA request focuses on product labeling for Bydureon, which is the proposed trade name for exenatide, along with risk mitigation and manufacturing information.

The FDA response does not contain requests related to a December preapproval inspection of a manufacturing facility in Ohio.

Amylin said it is “working diligently” to submit a response to the FDA in the next few weeks.

Bydureon, or exenatide, is a once-weekly version of the injectable treatment Byetta, which is currently taken twice daily. It is part of the broader GLP-1 class of drugs, which work by increasing the body’s insulin production.

The FDA approved Novo Nordisk’s once-daily GLP-1 drug Victoza in January. That drug had been under review for two years as safety concerns slowed down the regulatory process. The FDA approved it with a warning over the risk of thyroid cancer.