Merck has announced that it is discontinuing the development of odanacatib, its 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 3 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 this month.
“We are disappointed that the overall benefit–risk profile for odanacatib does not support filing or further development,” said Roger M. Perlmutter, MD, PhD, President of 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 3 trial does not support further development.”
Source: Merck; September 2, 2016.