Trilipix CV Outcomes Study To Focus On Patients With High Triglycerides, Low HDL-Cholesterol
This article was originally published in The Pink Sheet Daily
FDA follows its advisory committee’s recommendation and requires a post-marketing study of Abbott’s fibrate to determine whether combination use with a statin provides a cardiovascular benefit over statin monotherapy in high-risk patients.
You may also be interested in...
Key question at the Oct. 16 advisory committee review could be whether FDA should wait for results from an ongoing cardiovascular outcomes trial before significantly broadening the prescription fish oil product’s approval to include adults with high triglycerides and mixed dyslipidemia.
Abbott Laboratories is facing a difficult proposition with its cholesterol franchise. At the May 19 review of the ACCORD-Lipid data on use of Trilipix with a statin, FDA's Endocrinologic and Metabolic Drugs Advisory Committee called for outcomes trials to determine whether the combination has value in a particular subpopulation.
Advisory committee says data inconclusive with subgroups and recommended another study to determine if there is increased risk in women and/or benefit for high TG, low HDL-C patients.