Merck ditches long-troubled bone drug
- Merck & Co. revealed Friday morning it would discontinue development of the beleaguered osteoarthritis drug odanacatib after an adjudication and analysis revealed a disproportionate safety concern.
- A pivotal Phase 3 trial showed the cathepsin K inhibitor drastically decreased the risk of fractures in post-menopausal women, but also increased the risk of stroke.
- Data from the analysis will be presented at the American Society of Bone Mineral Research meeting in September.
"We are disappointed that the overall benefit-risk profile for odanacatib does not support filing or further development,” said Roger M. Perlmutter, president of Merck Research Laboratories, in a statement.
Perlmutter's comments are particularly striking: the R&D head had touted the drug as one of the company's next big blockbusters at an analyst day held by the company in 2014. At the time, Perlmutter said the drug would be filed with the U.S. Food and Drug Administration by the end of 2014.
It was meant to be a follow-on to the blockbuster bisphosphonate Fosamax (alendronic acid), which lost patent protection in 2008. Odanacatib also symbolized Merck's major push to stay in primary care drugs.
Odanacatib has had a storied past. The drug was okayed by an independent data safety monitoring committee in mid-2012 after the late-stage study showed better-than-expected efficacy in fractures. Yet, Merck announced in 2013 the filing would be delayed due to some safety concerns.
Almost two years after the end of the Phase 3 trial, Merck elaborated on those concerns, telling analysts and investors odanacatib patients showed higher rates of adjudicated atrial fibrillation and stroke than those on placebo. At the time, the company claimed the drug still had a favorable risk/benefit profile.
It's unlikely this will be a major hit to Merck's current pipeline or financials going forward. Many analysts had already discounted the drug from their models when the New Jersey pharma failed to file a New Drug Application with the FDA in 2014.
- Merck Statement
- The Pink Sheet Merck Moves Forward With Odanacatib Filing; FDA Accepts MK-3475 Filing
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