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Fenofibrate (TriCor) active metabolite approved

In a previous posting we commented on the battle between Abbott and Teva over Abbott’s generic defense strategy.  Yesterday (12/15/2008), FDA approved Abbott’s TriLipix – fenofibric acid.  Fenofibric acid is the active metabolite of fenofibrate.  The approval includes an indication to allow use in combination with a statin.  In fact, it was announced that Abbott and AstraZeneca are co-developing a combination tablet containing TriLipix and Crestor (rosuvastatin calcium).

Of course, Abbott could use the 505(b)(2) process to develop another statin combo but big pharma doesn’t often do this because they need the IP protection and co-promotion.  Someone could still do fenofibrate plus an off-patent statin if IP could be addressed.

TriLipx was approved based on a 2700 patient clinical study with high levels of LDL and triglycerides and low levels of HDL.  Patients were trated with either a statin alone (the comparator) abd the statin plus TriLipix.  Abbott states that patients on the comination had greater improvement in trigyceride and HDL levels than those patients on statin alone.  LDL levels were similar between treatment arms.