The FDA Declines to Approve Bydureon, a New Once-Weekly GLP-1 Agonist (Continued)
Thus, it is very surprising and discouraging that the FDA has requested this data now, when many doctors and patients were excited about access to this new compound. Perhaps most frustrating is that the FDA had deemed the cardiovascular data in kidney-impaired individuals from the DURATION-1 study adequate at the time Bydureon was originally submitted. So the FDA had the opportunity to ask for this study nearly seven months ago in the first complete response letter. We believe this exemplifies the FDA's increasingly poor ability to communicate adequately and in a timely fashion, as its mission suggests it should. With Bydureon's remarkable profile (nearly two points in A1C reduction, weight loss, much less nausea than Byetta, convenience of a once-weekly shot), we would have thought at least the FDA could have approved the drug in a population that did not include individuals with impaired renal systems, assuming this is the population in question.
Since 2008, the FDA has placed increasing emphasis on the cardiovascular safety of new diabetes drugs, arguing that these drugs should not increase the risk of cardiovascular complications when individuals with type 1 and type 2 diabetes are already at significantly higher risk for those complications. Notably, cardiovascular complications are the leading cause of mortality among individuals with diabetes. While that is certainly a reasonable concern, we view the FDA's decision on Bydureon as excessive, given the lack of any signal for a a cardiovascular safety issue and the amount of data already submitted. This decision is most disappointing for individuals with type 2 diabetes who are struggling to adequately control their blood glucose and that may have greatly benefited by what we believe is a remarkable drug. Meanwhile, of course, without Bydureon on the market, millions will continue to be diagnosed with long-term complications who could have benefited from better drugs earlier in their therapy.
What next? Well, this is certainly not to say that the drug will never be approved. In fact, many in the diabetes community, especially researchers and doctors involved in studying the drug, appear confident the Bydureon will eventually gain approval. The companies have estimated that it may take until the end of 2011 to design, carry out, and submit the results of the requested cardiovascular study to the FDA. Following this submission, the FDA would have six months to review the data and decide again whether to approve Bydureon. Consequently, approval of Bydureon may not come until mid-2012. We'll keep you updated!
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NOTE: This information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.
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I was in Dunkin' Donuts this morning. The one in Pawtucket, Rhode Island on Broadway actually offers some gluten-free selections and I was craving a breakfast sandwich. Waiting in line, I overheard two men at the counter - clearly regulars who sit for hours and shoot the sh*t over morning coffee and donuts. "I gotta be cay-ful too many donuts no good, I got tha shuuu-gah." "I didn't know you had the shu-gah. All the crap you eat,...