Drug Development

Stroke risk forces Merck to scrap its long-neglected PhIII osteoporosis drug odanacatib

Merck is scrapping its Phase III osteoporosis drug odanacatib after concluding that the drug increased the risk of strokes among patients taking the drug.

Roger M. Perlmutter, Merck, Executive Vice President and President of Merck Research Laboratories

Roger M. Perlmutter, Merck, Executive Vice President and President of Merck Research Laboratories

In a statement early Friday, Merck noted it had “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.”

Odanacatib once loomed large in the Merck pipeline, but has largely been relegated to the sidelines over the last couple of years, rarely mentioned by top execs. I reported the latest data in the fall of 2014, noting that investigators flagged a slight increase in the risk of atrial fibrillation as well as more strokes in the odanacatib crowd. Some analysts concluded that the drug was likely going to be worth only about $300 million a year to Merck, and that was it for odanacatib.

Roger M. Perlmutter, M.D., Ph.D., president, Merck Research Laboratories, had this to say:

“We are 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. 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.”

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