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Certriad approval may be delayed until mid-2011
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The FDA’s potential request for a post-approval outcomes study due to recent ACCORD trial findings may delay approval of Abbott’s Certriad combination therapy until mid-2011.
The FDA recently sent a complete response letter for the new drug application of the fenofibric acid (TriLipix, Abbott) and rosuvastatin (Crestor, AstraZeneca) combination therapy, which is intended to treat mixed dyslipidemia, according to a report from Abbott.
“The companies are currently evaluating the complete response letter; will continue discussions with the FDA to determine next steps with respect to the Certriad new drug application; and will respond to the agency’s request for additional information,” according to a statement from AstraZeneca.
Abbott also indicated that the FDA may be awaiting the outcome of a mid-2010 panel to be convened for the evaluation of the ACCORD results.
Results from the ACCORD trial — an evaluation of simvastatin (Zocor, Merck) and fenofibric acid (TriCor, Abbott) combination therapy in patients with type 2 diabetes — suggested that patients assigned to the combination therapy derived no benefit in terms of CV event reduction when compared with those assigned to simvastatin alone. However, Abbott stated that TriCor is not indicated for use with a statin, whereas TriLipix is.
The ACCORD results were presented at the American College of Cardiology 59th Annual Scientific Sessions in Atlanta.
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