The FDA's latest disappointing decision, and extending a personal invitation to celebrate World Diabetes Day with the diaTribe team

Excitement is abounding for me on one big thing this month – much improved glucose control and feeling better. What’s up? I’ve been taking Victoza and I write in this month’s Test Drive about the possibility of the drug class being approved, eventually, for people with type 1 diabetes in addition to type 2. See inside for my personal experience taking Victoza, which has been fantastic. Note that this is “off-label” use and this definitely shouldn’t be construed as a recommendation – it’s just news I wanted to share, along with some bigger-picture recommendations for Novo Nordisk.

Meanwhile, with Halloween here and Thanksgiving right around the corner, we are easing our way into the holiday season. For those involved in diabetes, late October through late December this year has come to take on a different sort of anticipation. Throughout 2010, several new diabetes therapies have been under review by the FDA, and, after much anticipation, the agency is finally getting ready to release its decisions on approval of these drugs in the US.

Leading off (I had to use a baseball reference, with our beloved San Francisco Giants just winning the pennant!), was Bydureon. Like many scientists, researchers, clinicians, and patients, I've been so excited about Bydureon – which is a once-weekly version of Byetta – since the day I first learned of its development in 2006. This is a once-a-decade kind of drug that could help millions of individuals with diabetes, and nearly everyone, including myself, thought that the drug was a lock for approval given its remarkable therapeutic benefits and lack of any significant safety concerns. Therefore, I was stunned when the FDA decided to delay its approval last week.

Because I've lived with diabetes for so long, because I know the sacrifices that must be made to remain in good health, and because I think daily about those who are in this boat with me – well, let’s just say, I find that I must remain positive about diabetes and obesity every single day, because I would otherwise go crazy. But after hearing decisions such as these by the FDA, it’s hard to stay positive. The FDA says right in its mission that it is responsible for advancing public health to speed innovations that make medicine more effective, safer, and more affordable. So, last March 15, the FDA delayed Bydureon for the first time, and it ostensibly worked with Amylin Pharmaceuticals and Eli Lilly (the makers of Bydureon) to show them what had to be done to get a drug approved that, by anyone's definition, advances public health.

The FDA now says it wants a thorough study of the impact of the drug’s main component, exenatide, on heart muscle. Our Learning Curve this issue goes into the reasons behind our surprise, starting with the fact that there wasn't mention of the need for this study in that very first response by the FDA in March, and going on to there being no evidence of adverse effects on the heart with Bydureon. Using conservative estimates, the earliest Bydureon could now be approved is in the middle of 2012.

While it’s hard to know why exactly the FDA has thrown up another hurdle, we are worried that the FDA’s increasing cautiousness and seeming over-emphasis on cardiovascular safety of new diabetes medications may stifle innovation and new drug development, something that we absolutely cannot have. Not now, not ever. It’s enough to turn the greatest optimist into a cynic. We are all crossing our fingers and hoping that the FDA decides to approve Linjeta (an ultra-fast acting insulin) on October 30 as well as Afrezza (a new inhaled insulin) on December 29. We will keep you updated as these decisions come around.

Finally, I would like to remind all of you that World Diabetes Day is rapidly approaching on November 14. For those of you unfamiliar with this day, it is a diaTribe favorite as communities around the world honor every individual living with or caring for an individual with diabetes by lighting up local monuments, office buildings, and houses in blue. The day is truly inspiring, and we invite everyone to come celebrate World Diabetes Day with us in San Francisco as we light up the Metreon, or, if you are unable to join us, to show your support by lighting up your own house or office building. For more information on this day, please see the New Now Next article in this issue. Also, be sure to keep an eye out for our special World Diabetes Day themed diaTribe issue in two weeks time.  Enjoy!

Yours truly,

Kelly L. Close