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news.Merck said it would stop the development of its experimental osteoporosis drug, odanacatib, because it carries a higher risk of stroke.
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An independent adjudication and analysis of major adverse cardiovascular events confirmed an increased risk of stroke.
The company said while odanacatib reduces the risk of osteoporotic fractures, the increased risk of stroke in a late-stage study in postmenopausal women does not support further development to seek regulatory approval.
The company will present the data at the American Society for Bone Mineral Research.
Merck Research Laboratories president Roger Perlmutter said the company is disappointed that the overall benefit-risk profile for odanacatib does not support filing or further development.
“We are very thankful to the researchers and patients who participated in the odanacatib clinical development program.”
Merck originally planned to file a new drug application in the US in 2015 despite the safety issues.
The company also planned to submit applications to the European Medicines Agency and the Ministry of Health, Labour, and Welfare in Japan.
If developed, odanacatib was believed to selectively inhibit cathepsin K, the primary enzyme in the osteoclasts that digests proteins during bone resorption.
Progressive increases in bone mineral density have been demonstrated with odanacatib.
Image: Merck is discontinuing the development of odanacatib, its investigational cathepsin K inhibitor for osteoporosis. Photo: courtesy of jk1991 at FreeDigitalPhotos.net.