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News Breaks
February 1, 2013
07:05 EDTMRKMerck says now anticipates odanacatib filing in 2014
Merck reported it recently received and is reviewing safety and efficacy data from the pivotal Phase III trial of odanacatib, the company’s investigational medicine for osteoporosis. As previously indicated, the company has been conducting a blinded extension of the trial in approximately 8,200 women, which will provide additional safety and efficacy data. Merck now anticipates that it will file applications for approval of odanacatib in 2014 with additional data from the extension trial, rather than filing in the first half of 2013. The company continues to believe that odanacatib will have the potential to address unmet medical needs in patients with osteoporosis.
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