科研之友
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摘要
An FDA advisory committee voted against approval of a drug that reduces triglyceride levels, since several clinical trials revealed no cardiovascular benefit from other such drugs. This summary of panel deliberations highlights challenges in the development of lipid-disorder treatments. On October 16, 2013, the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration (FDA) voted 9 to 2 against approval of Vascepa, a purified n-3 fatty acid formulation of ethyl eicosapentaenoic acid (EPA), for use as an adjunct to diet and in combination with a statin to reduce levels of triglycerides, non-high-density lipoprotein (non-HDL) cholesterol, apolipoprotein B, low-density lipoprotein (LDL) cholesterol, and very-low-density lipoprotein (VLDL) cholesterol in adult patients with mixed dyslipidemia and coronary heart disease or an equivalent risk of coronary heart disease. The sponsor and the FDA had previously agreed under a Special Protocol ...
- 出版日期2014-1-30
