Developers ready blockbuster diabetes drugs for review

Several developers will put the FDA's tougher safety standard for diabetes drugs to the test in coming months as they push for a slate of new approvals.

In early April Bristol-Myers Squibb and AstraZeneca's saxagliptin will face a crucial panel review the day before Novo Nordisk's liraglutide faces its expert test.  And Amylin Pharmaceuticals along with Eli Lilly and Alkermes intend to seek a green light to market exenatide LAR, an extended-release version of Byetta, by the end of the second quarter. To get past regulators, the FDA-anxious to avoid a repetition of the fiasco involving Avandia--has made it clear that regulators want more heart risk data for review.

If approved, the new products will jockey for position in a multibillion-dollar market. As the AP notes, these new drugs follow different disease channels to achieve better control of blood sugar with fewer injections. Analysts, though, say that Amylin in particular may face a regulatory challenge of its cardiovascular risk analysis. Researchers intend to use data from a meta-analysis review involving Byetta rather than exenatide LAR.

"This analysis was done in a manner consistent with the FDA updated guidance for evaluating cardiovascular risk in type 2 diabetes agents," the company said in a statement.

- read the AP report
- check out release on exantide LAR
- read the story in the San Diego Business Journal

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FDA seeks tougher labeling for Byetta after deaths
Analyst sees tighter diabetes drugs standards