Merck/Schering's Vytorin Clears FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Zetia/Zocor fixed-dose combination will be marketed as a first-line therapy for cholesterol.
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Merck/Schering-Plough's ezetimibe/simvastatin fixed-dose combination Vytorin was approved by FDA for the treatment of high cholesterol on July 23. The user fee deadline for Vytorin - which combines the active ingredients in Zocor (simvastatin) and Zetia (ezetimibe) - was officially July 24, but FDA wanted to complete the NDA review before the weekend. The Merck-Schering joint venture expects to position Vytorin as a first-line therapy, while Zetia, which was approved in November 2002, will be targeted to patients who have not reached their cholesterol goals. Merck maintained that it can keep cannibalization of Zocor at a minimum. While Vytorin will directly compete with simvastatin as a first-line option, the company expects the fixed-dose combination to take most of its share from Lipitor. Vytorin is also expected to benefit from the revised National Cholesterol Education Program guidelines, which stress more aggressive treatment goals. The approval is a much-needed positive for both companies. - Kate Rawson |