The Food and Drug Administration is also considering whether to add data from the clinical trial to TriLipix’s prescribing information, the report said. Outside advisers to the agency will consider the proposed options at a meeting on Thursday in Silver Spring, Md.
The review focuses on a study released in March 2010 comparing Abbott’s TriCor, an older version of TriLipix also known as fenofibrate, to the generic cholesterol pill simvastatin. New restrictions may jeopardize sales of TriLipix, which together with TriCor generated $1.58 billion last year, or 4.5 percent of Abbott’s revenue.
“Since complete data were not available, it is difficult to definitively assess the safety profile of fenofibrate plus simvastatin versus simvastatin plus placebo,” the F.D.A. said in its staff report.
The trial, named Accord, followed about 5,500 patients with Type 2 diabetes who were at high risk of developing heart disease, for an average of almost five years. Study results showed no significant reduction in the number of heart attacks, strokes and cardiac deaths in people taking TriCor along with simvastatin, compared with those taking simvastatin alone.
The F.D.A. is asking its advisory panel to weigh several options: whether TriLipix should be withdrawn for use with a statin; continue to be used with a statin with data from the study added to the prescribing information; tested in a new study; or face no changes.
TriLipix is the focus of the F.D.A.’s review because TriCor is not approved for use in combination with a statin treatment.
About two-thirds of the study participants did not have high triglycerides and low levels of good cholesterol, two criteria for use in the drugs’ prescribing information, Jim Stolzenbach, head of cardiovascular development for Abbott, said in a telephone interview. Patients who met those criteria benefited from TriCor, he said. The trial was financed by the National Institutes of Health.
The risk to Abbott will be minimized because TriCor is already expected to lose revenue when cheaper copies enter the market beginning in mid-2012, according to Larry Biegelsen, an analyst at Wells Fargo in New York. He estimates that sales will fall to $990 million next year because of generic competition.
Abbott said in October that about 30 percent of patients had switched from TriCor to TriLipix, a delayed-release version that was approved in 2008.
Last year, Abbott abandoned efforts to win approval for Certriad, an experimental heart pill that combined TriLipix with Crestor, from AstraZeneca.
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