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New FDA Rules for New Diabetes Drugs

Apr 1, 2008

Because of all the news about Avandia increasing cardiovascular deaths, Rezulin causing more deaths from liver failure, and things like discontinuation of the intensive arm of the the ACCORD study, etc, Late-stage diabetes drug trials will be longer and costlier with new FDA guidelines aimed at boosting drug safety, and some small biotechs are feeling the pinch. The Food and Drug Administration issued draft guidelines in late February that require, among other points, that Phase III trials for type 2 diabetes drugs cover 2,500 patients and expose some 500 of them to a drug for more than 18 months. The compares to current rules of 1,500 patients, with 100 exposed to the drug for a year.

While not formal rules yet, draft guidance statements from the FDA generally are considered a done deal by pharmaceutical and biotech companies as they set up their clinical trials.


That’s got some companies — especially smaller biotechs — worried as they seek funding that will push their drugs into longer pivotal trials, which translate into a longer time investors will wait for a return on investment.
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