Amylin Pharmaceuticals is working on something they’re hailing as a potential miracle drug: the first-ever once-weekly diabetes treatment that’s guaranteed to bring down your blood sugar levels and help you lose weight and keep it off. It certainly sounds amazing, no?
The drug is a new “extended” version of exenatide (commercial name: Byetta, an injectable used to treat Type 2 diabetes) that will be submitted for FDA approval by the end of 2009. It belongs to a class of drugs called GLP-1s, gut hormones that lower glucose levels by increasing insulin secretion from the pancreas and suppressing the release of glucagon (glucose in the bloodstream). It also curbs your appetite by slowing gastric emptying.
In studies, patients testing the new long-acting drug achieved an AVERAGE of a two percentage-point drop in their A1C (measure of glucose levels over the last three months), and also lost an average of 9.5 pounds and kept the weight off for at least six months, Amylin reports. That kind of impact is extraordinary, to be sure
The company is positioning this new once-weekly as the “missing link” in diabetes care due to the killer combination of these unprecedented results, and the fact that it will be so easy to use that patients can and will more consistently stick to their treatment regimen.
They say it can also be safely combined with metformin and other oral drugs, and they’ll be studying its efficacy against these drugs and also against insulin itself in the next few years.
At a recent healthcare investor’s conference in San Francisco, where I learned about the drug, Amylin was even quoting prominent physicians as saying this drug – when it’s ready for market – will create an entirely “new class of treatment for Type 2 diabetes.”
Wow! I hope they are right. We hear about potential miracle meds all the time, so it’s wise to take this news with a grain of salt as well. As always, there are some good reasons for optimism and pessimism alike:
A bit about Byetta:
The current version of Byetta is administered in an injection pen with a tiny needle twice daily, usually before the first and last meal of the day. Because of its effectiveness with glucose control and weight loss, Byetta has quickly become one of the most widely prescribed diabetes treatments in the US.
However, its main side effect is nausea and other gastrointestinal discomfort, so it’s not meant for people who already have problems in that area. Also, there was a recent safety scare when several patients using the drug showed up with acute pancreatitis, including several deaths. But the FDA has continued to sanction the drug since no definite causal relationship has been established.
One potential roadblock is tightening FDA regulations for approval of all new diabetes drugs. After the evidence that a controversial drug called Avandia may significantly increase patients’ risk of heart attack, the FDA is cracking down with stringent new research requirements. Some folks are worried that this may slow down approvals of new diabetes drugs “to the pace of molasses.”
Let’s hope they can strike a balance between safety and progress towards innovative new treatments. Because according to experts like diabetes researcher Andre J. Scheen, MD, PhD, of Belgium's University of Liege, the once-weekly version of exenatide will provide better blood sugar control and reduced nausea. “This new strategy might substantially change the management of Type 2 diabetes," he writes.