Sometimes you roll the dice. And sometimes you end up with snake eyes.
Today Amylin Pharmaceuticals
The companies only needed Bydureon to be as good as Victoza for the trial to be a success. Bydureon is only injected once a week compared with Victoza's daily needle pricks. Unfortunately, the drug couldn't even manage that; Bydureon lowered patients A1C level, an indicator of average blood sugar, by 1.3 percentage points, compared with a reduction of 1.5 percentage points for Victoza.
The full data set isn't out yet, and it's possible that some of the other measurements -- weight loss, for instance -- could end up in favor of Bydureon, but this is still a major blow as A1C level is the gold standard for diabetes clinical trials.
The results won't keep Bydureon off the market; a 1.3 percentage point reduction is still impressive, and Amylin expects to submit an application for a third time in the second half of the year.
But once it makes it to market, the data is going to make it harder for Amylin and Eli Lilly to push the drug. The fewer injections that Bydureon provides are a great benefit, but it may not be enough to overcome the seemingly inferior efficacy.
The companies were setting up Bydureon as the go-to drug between oral medications and daily injections. With the increase in oral medications -- Bristol-Myers Squibb
Craps, indeed.
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