Amgen has submitted new re-adjudication data alongside real-world, post-marketing and meta-analysis studies in support of avacopan, arguing the drug maintains a positive risk-benefit ratio and should remain on the market.In a 104-page document submitted to the FDA and provided to Healio, representatives from Amgen also rejected allegations levied by the FDA that employees of avacopan’s

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Amgen has submitted new re-adjudication data alongside real-world, post-marketing and meta-analysis studies in support of avacopan, arguing the drug maintains a positive…