FDA requests complete response regarding new diabetes drug

Bydureon development partners Amylin, Eli Lilly and Alkermes announce that the FDA has issued a response letter regarding their NDA, requesting additional information, but not new preclinical or clinical data

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SAN DIEGO—The three companies which have collaborated on the development of Bydureon (exenatide for extended-release injectable suspension)—Amylin Pharmaceuticals Inc., Eli Lilly and Co. and Alkermes Inc.—have announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for the investigational medication for type 2 diabetes. On the day the news broke, shares of Amylin Pharmaceuticals jumped 9 percent. Alkermes shares also rose about 10 percent. The company is providing the long-acting technology for Bydureon.

Neither Amylin nor its partners were asked to conduct additional studies on the much anticipated drug, which is a once-weekly version of the twice-daily Byetta injection. The FDA request focuses on product labeling for Bydureon, along with risk mitigation and manufacturing information. Amylin plans to respond to the FDA request within the next few weeks.

The complete response letter does not contain requests related to the December 2009 observations from the FDA's pre-approval inspection at Amylin's Ohio manufacturing facility. All of those observations have been addressed. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes. (Editor's Note: The FDA letter led to a spate of headlines on March 15 that the FDA had "denied" approval of the drug, when in fact this only represents a delay in getting it approved)

"This is a significant step forward in our ability to bring this important therapy to patients," says Dr. Orville G. Kolterman, senior vice president of research and development at Amylin. "We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks." Kolterman reiterated that the FDA has not requested any new data or additional analyses.

Bydureon is part of the broader GLP-1 (glucagon-like peptide-1) class of drugs, which work by increasing the body's insulin production.  Other physiological functions include a decrease in glucagon secretion from the pancreas, inhibition of acid secretion and gastric emptying in the stomach and a decrease in food intake by increasing satiety. 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 regulatory approval. The FDA did eventually give the go-ahead, with a warning about the risk of thyroid cancer. Byetta (exenatide) injection has been available in the U.S. since June 2005 and has been prescribed in 10 million scrips, Kolterman notes. It is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes.

In a follow-up investor conference call hosted by Amylin president and CEO Daniel Bradbury and Dr. Kolterman, much of the questioning centered on the REMS issue. In response to questions related to safety, Kolterman told conferees that updated safety data is a standard part of a complete response and that Amylin will include such data from additional duration studies. Based on post-marketing data, Byetta has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Speaking to the concerns about thyroid cancer related to Victoza, Kolterman said that no calcitonin data will be included in Amylin's response but that it is being studied. He notes that Amylin is pursing a line extension strategy so pancreatitis will be one pull-through that continues to be monitored. Amylin expects to enjoy a price premium for once-a-week Bydureon versus once-a-day dosage forms. The company plans to launch the product within two months of receiving approval.

Diabetes affects more than 24 million people in the U.S. and an estimated 285 million adults worldwide with 90-95 percent of those having type 2 diabetes. It is the fifth leading cause of death by disease in the U.S. and costs approximately $174 billion per year in direct and indirect medical expenses. According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen. In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese. Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.

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