The Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) recently met to evaluate data from the Action to Control Cardiovascular Risk in Diabetes-Lipid (ACCORD Lipid) study.
The randomized, double-blind, placebo-controlled add-on ACCORD Lipid study was conducted to evaluate the efficacy and safety of adding fenofibrate therapy to Merck’s (MRK) Zocor (simvastatin) in type II diabetes patients. Results from the study showed that the addition of fenofibrate to statin did not result in a statistically significant difference in patients who had experienced a major adverse cardiac event compared to patients on placebo plus statin.
The FDA’s advisory panel discussed the impact of these findings on Abbott Labs’ (ABT) TriLipix (fenofibric acid). TriLipix is approved for use with a statin for lowering triglycerides and raising high-density lipoprotein cholesterol in patients with mixed dyslipidemia and coronary heart disease or at high risk of coronary heart disease.
The panel voted in favor of retaining the TriLipix indication for use in combination with a statin. However, the panel said that additional clinical data should be generated to support the use of fibrates in combination with statins.
Abbott Labs noted that two-thirds of patients in the ACCORD Lipid study would not qualify for treatment with fibrates under the current treatment guidelines issued by the National Cholesterol Education Program (NCEP).
The FDA is yet to deliver a final decision regarding TriLipix' label. While not required to do so, the agency usually follows the recommendation of its advisory panels. Combined sales of TriLipix and TriCor were $1.6 billion in 2010, up 18.3%.
Neutral on Abbott Labs
We currently have a Neutral recommendation on Abbott Labs, which carries a Zacks #3 Rank (short-term Hold rating). We believe Abbott Labs is weathering the storm relatively well despite facing challenges like the impact of US healthcare reform, product recalls, foreign exchange headwinds and EU pricing austerity. Abbott Labs’ strong business segments and contributions from recent acquisitions should help fortify long-term earnings growth.
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