Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear
US FDA advisory committee splits on whether Amgen's osteoporosis drug romosozumab needs observational study or randomized controlled trial to assess cardiovascular risks.
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Strict conflict of interest rules have hampered the agency's ability to fill advisory committee vacancies.
Evenity's Postmarketing Requirement Includes Feasibility Component Familiar To Other Osteoporosis Drugs
Amgen might have to conduct a randomized CV outcomes trial for Evenity if it's possible; a Pink Sheet analysis reveals that feasibility has been a factor in the US FDA's postmarketing requirements and commitments for other osteoporosis drugs as well.
Amgen EVP Murdo Gordon highlighted the unmet need for women at high risk, including those with a prior fracture. At $1,825 per month or $21,900 for a one-year course in the US, he says Evenity's cost is much lower versus competing 18- and 24-month anabolic agents.