Dohme announces Phase III results for odanacatib trial
12 July 2012 11:28 in Pharmaceutical Company Restructures
Merck Sharp & Dohme has revealed that its Phase III trial of odanacatib, the investigational cathepsin K inhibitor, could be closed early thanks to robust efficacy ratings and a favourable benefit-risk profile.
The Data Monitoring Committee for the study made these recommendations following its interim report on the treatment, which could reduce the risk of fracture in post-menopausal women with osteoporosis.
Peter S Kim, Merck Sharp & Dohme executive vice-president and Merck Research Laboratories president, expressed his pleasure at the results.
"We are encouraged by the ... recommendation to close the trial early ... and look forward to reviewing the data with the scientific community to bring forward this innovation," he added.
Final results of the study could be published in 2013 once analysis of the data is complete, with plans to submit regulatory approval applications to the US, EU and Japan early next year.
This follows Merck Sharp & Dohme's recent decision to work with the Bill & Melinda Gates Foundation to expand global access to family planning services.
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