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US FDA Sends Amgen/UCB Evenity Back With BRIDGE Request

Executive Summary

The US FDA has surprised no-one with a Complete Response Letter for Amgen and UCB's novel osteoporosis treatment Evenity but, with luck, analysts say the product might still reach the market in 2018-19 and garner sales over £500m.

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Amgen Launches Evenity For High-Risk Osteoporosis At $21,900 List Price

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.

Amgen's Evenity Clears US FDA With Preferred Indication, Black Box Warning

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Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear

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