Amgen/UCB's Phase III Success May Not Be Enough To Top Osteoporosis Rivals
This article was originally published in The Pink Sheet Daily
Romosozumab shows ability to reduce risk of spinal fractures, but misses a secondary endpoint on nonvertebral fracture risk reduction.
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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.
Effective medical device regulation supports both safety and innovation needs. This article assesses how well the US FDA and the Australian TGA achieve this balance.