Washington, DCDespite growing concerns over the link between Byetta and acute pancreatitis, the manufacturers of Byetta plan to introduce a longer-acting form of the medication to be taken just once weekly. The US Food and Drug Administration (FDA) has set October 22 as the target date for a decision regarding approval of Bydureon.
The 5/6/10 issue of the Boston Business Journal (BBJ) reported that Bydureon, a co-production of Alkermes, Amylin Pharmaceuticals and Eli Lilly and Co., was rejected by the FDA earlier this year. BBJ reported that the original application was filed a year ago May. In March 2010 the FDA issued a complete response letter, to which the three manufacturers have reportedly responded with additional data in an effort to see their drug approved.
The original Bydureon application was based on data from the DURATION trial as well as seven years of clinical experience with Byetta (exenatide) injection.
It is assumed the data for Byetta will include various reported side effects, including acute pancreatitis, fatal and non-fatal hemorrhagic or necrotizing pancreatitis.
The most common side effects with Byetta include nausea, vomiting, diarrhea, dizziness, headache, jitteriness, and acid stomach. Patients most commonly experience nausea when first starting Byetta, but the sensation decreases over time.
However, acute pancreatitis is by far the most severe risk associated with Byetta. The 5/6/10 issue of PR Newswire notes that Byetta should not be prescribed to people who have severe kidney problems, and should be used with caution by people who have had a kidney transplant. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or trouble digesting food.
The release did not mention whether Byetta side effects might be magnified or mitigated if administered in a once-weekly injection.
Approved by the FDA in 2005, Byetta is the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 65diabetes. Since that time the FDA has received dozens of reports related to Byetta acute pancreatitis, as well as kidney failure and other kidney issues. The agency has since issued a number of directives to health care professionals—the latest in November 2009 when the FDA noted the addition of new prescribing information related to kidney concerns.
In April, federal drug safety reviewers noted that Byetta side effects could include thyroid cancer, an adverse reaction not unlike that of other similar medications. The suggestion was made that Bydureon, if approved, would arrive with a black box warning, although the press release made no mention of that with regard to the FDA timeline for the anticipated approval of Bydureon.
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