FDA approval requested for Crestor-Trilipix combo

The pharmaceutical industry's latest proposed merger wasn't about turning two companies into one but about uniting two widely used dyslipidemia drugs in a single pill. Abbott Laboratories and AstraZeneca have asked the FDA to approve a combination of their products fenofibric acid (Trilipix) and rosuvastatin (Crestor), respectively, for the treatment of mixed dyslipidemia, the companies have announced . If they get their wish, the product will be sold as Certriad.

In December, as reported by heartwire, Trilipix became the first fibrate to be approved for use with a statin, although in actual practice the two drug classes are frequently combined.

Together, rosuvastatin and fenofibric acid can reduce high LDL-cholesterol and triglyceride levels and raise low HDL cholesterol. The companies note that their application to the FDA "is supported by data from multiple studies, including efficacy and safety studies with the 5-mg, 10-mg and 20-mg doses of rosuvastatin combined with fenofibric acid."

In a separate announcement, the two companies said they have agreed to "copromote" Abbott's Trilipix within the US for monotherapy or in combination with a statin .

Source : www.theheart.org

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