Resources for Food and Drug Administration (FDA)

New Guidelines, Safety Issues Reshape Diabetes Space

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The diabetes landscape is a tad riskier for drugs in development that have a safety glitch or two, and the bottom line could mean higher costs.

New FDA draft guidance calls for more patients and lengthier trials for companies with certain safety issues, but the rules are no different from what is expected in drug development for other chronic conditions, the agency has said.

In general, the FDA wants companies to exceed previous expectations considering the growing diabetes population and the increased complexity of treatments, but it will be an absolute stickler with those drugs exhibiting serious side effects. Specifically, it wants a Phase III trial to include at least 2,500 subjects, with 1,300 of them exposed to the drug for a year or more, and 300 exposed for 18 months or more. Certain diabetes drugs on the market, such as Januvia (sitagliptin; Merck & Co. Inc.) and Byetta (exenatide; Amylin Pharma-ceuticals Inc. and Eli Lilly and Co.) were approved based on trials that didn't go beyond a year.

Some companies with early stage diabetes products say the new rules are in line with what was already planned for development. Sirtris Pharmaceuticals Inc., for instance, is working on SRT501, an oral small molecule formulation of resveratrol that activates Sirt1. It is in five Phase Ib trials.

"The draft guidelines will not impact our timetables," said John Lacey, associate director of corporate communications at the Cambridge, Mass.-based company, who added that its programs were "already meeting the draft guideline recommendations."

It is unclear, however,

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