Merck Provides Update on Odanacatib Development Program
September 2, 2016 6:00 am ET
Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that it is discontinuing the development of odanacatib,
Merck’s investigational cathepsin K inhibitor for osteoporosis, and will
not seek regulatory approval for its use. Merck 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. The data from the analysis will be presented at the
American Society for Bone Mineral Research (ASBMR) in September.
“We are disappointed that the overall benefit-risk profile for
odanacatib does not support filing or further development,” said Roger
M. Perlmutter, M.D., Ph.D., president, Merck Research Laboratories. “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.”
About Merck
For 125 years, Merck has been a global health care leader working to
help the world be well. Merck is known as MSD outside the United States
and Canada. Through our prescription medicines, vaccines, biologic
therapies, and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
health care through far-reaching policies, programs and partnerships.
For more information, visit www.merck.com
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Merck
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