After D-mab: Next-Generation Osteoporosis Drugs Focus On Building Bone
This article was originally published in Pharmaceutical Approvals Monthly
Amgen's osteoporosis and bone-related cancer drug denosumab may be one of the most eagerly-anticipated approvals of the year - not least by Amgen itself, whose future growth depends almost entirely on an FDA nod. But in another sense this antibody marks an ending, not a beginning
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New bone-targeted agents for osteoporosis must clear significant obstacles to succeed in a highly generic market, but safety concerns with established agents like bisphosphonates and calcitonin offer a foothold. Phase III anabolic candidates from Amgen and Radius Health aim to build new bone, the holy grail of osteoporosis treatment, but R&D in new anti-resorptive mechanisms to halt bone breakdown also continues.
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Analyst questions whether the bone drug’s efficacy can beat Zometa’s by the necessary 15 percent.