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Development of odanacatib discontinued
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The development of the cathepsin K inhibitor, odanacatib, for the treatment of osteoporosis has been discontinued, according to a press release from Merck.
The company also announced it will not seek regulatory approval for its use.
The company previously reported that there was an imbalance in adjudicated stroke events during the phase 3 fracture outcomes trial in postmenopausal women. The discontinuation of development comes after an analysis of major cardiovascular events confirmed an increased risk for stroke.
“We are disappointed that the overall benefit-risk profile for odanacatib does not support filing or further development,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release. “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.”