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.
Delaware district judge rules against AstraZeneca’s claim the IRA violates its due process rights, echoing findings made by Ohio district judge in Chamber of Commerce’s suit. Only other IRA ruling to date dismissed PhRMA’s complaint on procedural grounds without addressing the merits.