Merck Ends Development of Osteoporosis Therapy Due to Increased Stroke Risks

Merck is suspending development of its osteoporosis candidate after an analysis of its Phase III fracture outcomes study demonstrated that the therapy increases the risk of strokes.

The company said that an independent adjudication and analysis of major adverse cardiovascular events confirmed a rise in the risk for strokes. The analysis evaluated the results of a Phase III trial that studied the candidate in postmenopausal women.

The candidate reduced the risk for hip, spine and non-vertebral fractures compared to placebo in the trial. However, Merck reported 109 strokes among patients dosed with the candidate and 86 among those treated with the placebo.