Washington, DCThe manufacturers of Byetta continue to pursue their quest to bring a new, once-weekly injectable suspension to market. Known as Bydureon exenatide extended-release, the product provides much promise for diabetes patients who tire of daily injections, and is expected to do well. The prospect of having to undertake an injection once per week—rather than twice per day—should translate into healthy sales for the manufacturers if, and when, Bydureon comes to market.
But at what potential cost to the health of the consumer? And will Bydureon carry similar risks associated with Byetta, including Byetta acute pancreatitis?
Amylin Pharmaceuticals, Eli Lilly and Co., and Alkermes Inc. are trumpeting the fact that the US Food and Drug Administration (FDA) issued a complete response letter with regard to their New Drug Application (NDA) for Bydureon. To facilitate the process required to approve Bydureon for market, the FDA is requesting various studies in addition to the results of DURATION-5 in an effort to evaluate the efficacy, safety, effectiveness and labeling of the new product.
The October 19th issue of PR Newswire notes that the manufacturers' goal is to submit their reply to the complete response letter by the end of 2011, pending discussions with the FDA. Based on the requirements for additional data, this will likely be considered a Class 2 resubmission requiring a six-month review.
"We are committed to working closely with the FDA to resolve the issues raised in the complete response letter so that Bydureon can be approved, and we can make this important treatment available to patients with type 2 diabetes as quickly as possible," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "We remain confident in Bydureon based on the extensive exenatide database, including more than seven years of clinical experience with Byetta, the twice-daily form of exenatide...."
Since it was first brought to market, Byetta has been associated with various Byetta side effects, including Byetta acute pancreatitis, and fatal and non-fatal hemorrhagic or necrotizing pancreatitis. The risk for getting low blood sugar is higher if Byetta is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. Since the FDA approved Byetta for the US market in 2005, the government agency has received no fewer than 40 reports of acute pancreatitis related to Byetta. There have been six deaths reported.
Will Bydureon suffer from the same risks?
There is no question that the stakes are high. According to PR Newswire diabetes affects more than 24 million people in the US and an estimated 285 million adults worldwide, the vast majority of whom suffer from type 2 diabetes. Diabetes treatment and maintenance represents $174 billion per year in direct and indirect medical expenses.
Thus, what adverse reactions similar to Byetta side effects will be acceptable to the FDA in order for the makers of Bydureon to capitalize on such a burgeoning market? Time will tell.
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