FDA Hedges Approval of Long-Acting Byetta, Asks Amylin for More Information

The U.S. Food and Drug Administration has withheld approval of Bydureon, the once-weekly version of the popular type 2 diabetes drug Byetta.  The agency has asked its manufacturer, Amylin, for more information regarding Bydureon’s manufacture, labeling, and risk management plan. It did not, however, request further information on tests of the drug itself-an indication that the agency probably intends to grant marketing permission once it has dotted all the i’s and crossed all the t’s involved in the approval process.

The stock market reacted well to the news, taking the FDA’s delay in approval as a procedural matter rather than a rejection of the drug itself. In the wake of the news, Amylin shares were trading at eight percent higher than before.

Amylin is looking for Bydureon to reinvigorate its bottom line. Byetta, which has annual U.S. sales estimated at $700 million, has sold less well than hoped for over the past few years, in the wake of FDA concerns that it might be linked to several cases of fatal pancreatitis. In addition, Byetta has probably reached as large a market as it can since its introduction in 2005, given that it must be injected twice daily. For many type 2s, that is a more demanding drug regimen than they care to follow.

Bydureon, however, is injected only once a week. Time-release technology developed by Alkermes, Inc., delivers measured doses over the 168-hour span. Bydureon and Byetta are commercial names for exenatide, a GLP-1 (glucagon-like peptide-1) drug based on Gila monster saliva. They increase insulin production and sensitivity, lower glucose production, and often decrease appetite.  

Amylin said that it will respond to the FDA query within a few weeks, but nobody can say for sure when the FDA might give a final OK to Bydureon. In addition to the non-threatening nature of the FDA’s current questions about the drug, Amylin has other grounds for optimism: In January, the FDA approved Novo Nordisk’s Victoza, also a GLP-1 drug. 

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FDA Rejects Amylin Diabetes Drug, Seeks More Info 

Diabetes Drug From Lilly, Amylin Under Scrutiny Forbes

FDA asks for risk plan info on diabetes drug The Associated Press

Amylin, Alkermes Gain as FDA Needs No New Byetta Data BusinessWeek

Boston Globe

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