How would you like to manage your diabetes by taking your medicine just once a month?
You can’t do that yet. But that prospect is on the horizon.
While I seldom write about news that we can’t use at the moment, I think that this is such big news that many of you will want to know about it right now.
Only once before (if my memory serves me) have I ever written about a diabetes medicine that the U.S. Food and Drug Administration had not yet approved. That was in 2002 when I wrote about something then called Exendin-4 in my article “The Monster Drug.”
That monster drug, renamed exenatide -- made from the venom of Gila monsters -- became Byetta after the FDA approved it in 2005 as the first of a new class of drugs, GLP-1 agonists. Byetta became a monstrously successful medication for people with diabetes, including this writer. Full disclosure: I own some shares of stock in Amylin Inc., the company that developed Byetta.
When people take Byetta they inject it before breakfast and before dinner. That twice-a-day coverage isn’t quite as convenient as the second GLP-1 agonist, Victoza.
But when and if the FDA approves an extended release form of Byetta called Bydureon, taking it just once a week will be even more convenient.
Today’s news is about an even longer lasting form of exenatide. This is the biggest news announced at the 71st Scientific Sessions of the American Diabetes Association.
The ADA’s annual meeting is always the biggest diabetes gathering in the world. This year more than 17,500 people, including 14,000 scientists, physicians, and other health care professionals -- plus a few regular people and some journalists like me -- are meeting in San Diego, California, from June 24 to June 28.
The amount of information presented is staggering. I am making my way through more than 2,000 abstracts and more than 1,600 posters. But they seem to save the biggest news for what they call “Late-Breaking Posters,” some 131 in all. These posters got posted today.
The poster that captured most of my attention is “Safety and Efficacy of Once-Monthly Exenatide over 20 Weeks in Patients with Type 2 Diabetes” by six scientists who work for Amylin Pharmaceuticals Inc., which happens to be headquartered here in San Diego.
Posters are a strange thing. Before I attended my first ADA convention about five or six years ago I had heard of them, but because I had never seen one, I didn’t quite understand what they are.
The literally are a large piece of paper, usually about four or five feet wide and about three feet high presenting a few paragraphs each of abstract, background, methods, results, summary or conclusion, charts, and references. In other words, they follow the typical style that researchers use for published articles.
They put these posters up on easels in a large hall at the convention. Posters aren’t “published,” although I have a printed copy in an ADA handout, “Late Breaking Abstracts.” Posters are inherently preliminary, unlike peer-reviewed articles in scientific publications.
I took photographers of the poster about taking one shot of exenatide a month in hopes of sharing it with you here. Then, I read in the ADA’s handout that “use of photographs...may result in prosecution,” so like the good boy that I am I deleted the photos from my camera.
How strange this is, since the same handout includes essentially the same text as that poster. I could quote from it -- and not from my deleted photo -- but I have a third source written in something closer to the standard English that normal people use. This third source is a press release that Amylin and its marketing partners Eli Lilly and Company and Alkermes Inc. also put out today.
The once-monthly form of exenatide “showed substantial improvements in glycemic control, including reductions in A1C and fasting plasma glucose with modest weight loss,” the press release says. This 121-patient phase 2 study showed that after five injections in 20 weeks of treatment their A1C improved 1.3 percent with 5 mg and 8 mg doses and 1.5 percent with an 11 mg dose. This means, for example, that people who at the start of the study had an A1C of 8.5 were able to bring it down to 7.0.
Half of those who took the 5 mg dose, 57 percent of those who took the 8 mg dose, and 70 percent of those on the 11 mg dose got their A1C down below 7.0. They lost a little weight too, although the press release is careful to say that it is “not being studied as a weight-loss product.”I’m sure that the FDA would give them an even harder time if they made that claim, and Amylin has always been careful about weight loss claims from the time Byetta went on the market. For example, the company kept me at arms length as soon as they heard I was writing my 2008 book, Losing Weight with Your Diabetes Medication: How Byetta and Other Drugs Can Help You Lose More Weight than You Ever Thought Possible.
The study compared the once-a-month form with Bydureon, which is to be taken once a week. “Results for A1C, fasting glucose, and weight in the exenatide once monthly treatment arms were generally comparable to those seen in the Bydureon reference arm,” the press release states.Today I spoke with two pharmacists about the forthcoming once-a-week form of exenatide. Each of them had concerns.
One wondered if people taking it would have a lot of nausea at first. Yet the study shows that only 17 to 22 percent of people taking it experiened any nausea, less than half the proportion of those taking Byetta.
The other pharmacist told me that people would forget to take their shots sometimes because the time for taking them is so far apart. I told him that I was confident that their doctors and nurses would call them in to administer the shot or at least send them a reminder.
But that’s in the future, even further off than the U.S. approval of Bydureon. While the European Union gave Bydureon marketing approval earlier this month, in the U.S. we are still waiting for the FDA to act.
Published On: June 26, 2011