MSD drops osteoporosis trial drug due to stroke risk
pharmafile | September 5, 2016 | News story | Research and Development, Sales and Marketing | MSD, Merck, Odanacatib, osteoporosis, stroke
MSD, known as Merck in the US and Canada, has announced that it has finally decided to discontinue the development of osteoporosis drug, odanacatib, and will not seek regulatory approval for its use.
The investigational cathepsin K inhibitor has hit numerous stumbling blocks throughout the trial process, with the drug failing to make it past regulators as far back as 2013 due to its adverse events profile.
The company had previously reported that odanacatib, while the drug was effective at treating the disease, also increased the risk of atrial fibrillation and stroke. Numerous regulatory filings were either withdrawn or rejected due to these safety concerns.
MSD has finally terminated development of the drug after an independent adjudication and analysis of major adverse cardiovascular events confirmed the increased risk of stroke. Once touted as a potential blockbuster, MSD will have to rely on other development programs going forward.
Roger Perlmutter, president at Merck Research Laboratories, says: “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 programme.
“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 III trial does not support further development.”
Sean Murray
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