Merck Halts Development of Osteoporosis Drug Due to Stroke RiskBy
The company won’t file for regulatory approval of odanacatib
Findings will be presented at Bone Mineral Research meeting
Merck & Co. will halt development of an experimental drug to treat osteoporosis called odanacatib after a key study showed that older women taking it were more likely to suffer a stroke.
The risk was confirmed by an independent analysis of results from the final study needed to get a new drug approved, the Kenilworth, New Jersey-based company said Friday in a statement. Merck won’t pursue regulatory approval of the bone-strengthening medicine.
Merck, which originally planned to file for approval in 2013, faced delays as it conducted a second study to verify its safety and effectiveness. A first trial had been stopped early the previous year because the medicine worked so well, significantly reducing the risk of fractures in post-menopausal women. Analysts anticipated the drug would have reached about $230 million in sales in 2020, based on six estimates compiled by Bloomberg, a fraction of Merck’s annual revenue.
The shares rose 0.1 percent to $63.16 at 10:08 a.m. in New York. The full findings on the stroke risk will be presented at the American Society for Bone Mineral Research meeting in September.