Pharmaprojects R&D Pipeline News Feed
First approval for next-generation fibrate
18 Dec 2008
The US FDA has approved TriLipix (fenofibric acid), a next-generation micronized fenofibrate co-developed by Abbott and Solvay, for cholesterol management. Abbott will be responsible for marketing TriLipix in the US, while Solvay holds the rights to the rest of the world. It is also being developed in a tablet form (ABT-143), in combination with rosuvastatin calcium, for the treatment of hyperlipidaemia. Filing for approval of ABT-143 is expected next year.
Fibrates activate peroxisome proliferator-activated receptors (PPARs), primarily PPARa, which modulate carbohydrate and fat metabolism. Fibrates act on three key lipids, increasing 'good' high-density lipoprotein (HDL) levels and decreasing triglyceride levels, while also lowering 'bad' low-density lipoprotein (LDL) levels. LDLs transport cholesterol to arteries where it can be retained by proteoglycans to initiate the formation of arterial plaques associated with atherosclerosis.
While TriLipix has not been shown to prevent heart disease or heart attacks, clinical trials have demonstrated that when used in combination with the most commonly prescribed statins, TriLipix managed levels of three key lipids better than either of the corresponding therapies alone. Because of this, TriLipix is indicated for use with statins and diet. It is currently the first and only fibrate approved for use in combination with a statin for cholesterol management.
