Merck pulls the plug on odanacatnib
Increased risk of stroke fails to support further development.
Merck (MSD) is discontinuing the development of odanacatib, Merck’s investigational cathepsin K inhibitor for osteoporosis, and will not seek regulatory approval for its use. Merck previously reported a numeric imbalance in adjudicated stroke events in the pivotal Phase III fracture outcomes study in postmenopausal women. The company has decided to discontinue development after an independent adjudication and analysis of major adverse cardiovascular events confirmed an increased risk of stroke. The data from the analysis will be presented at the American Society for Bone Mineral Research (ASBMR) in September.
“We are disappointed that the overall benefit-risk profile for odanacatib does not support filing or further development,” said Roger M. Perlmutter, president, Merck Research Laboratories. “We are very thankful to the researchers and patients who participated in the odanacatib clinical development program. We have learned that odanacatib treatment reduces the risk of osteoporotic fractures. At the same time, we believe that the increased risk of stroke in our Phase III trial does not support further development.”
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