The FDA wants to pull its approval of a drug. It’s not so easy.
摘要
美国FDA曾就一款罕见自身免疫性血管炎实验性药物召开独立专家会议，因研究设计存在不足，药物疗效难以明确解读，部分专家对结果持保留态度。与此同时，部分患者和医生认为数据显示出潜在帮助，可能减少对类固醇的依赖。文章围绕FDA试图撤回该药批准所面临的困难展开。
In May 2021, the US Food and Drug Administration released a lengthy briefing document on an experimental medication for a rare autoimmune form of vasculitis that often damages the kidneys and lungs. The agency was on the fence about whether to approve the treatment, and it wanted an independent advisory committee to weigh in. Among the questions at hand: Was the drug meaningfully better than existing therapies?
Participants in the study, which had been conducted by the California biotechnology company ChemoCentryx, did appear to have slightly higher rates of symptom remission after one year. But according to the FDA, it was hard to interpret the results because the study’s design had been less than optimal. Some advisory committee members expressed a similar view. The effect of the drug, said one, “is just not well verified by this study.”
At the same time, many patients, and some physicians, saw in the data a potentially helpful medication, one that might lessen patients’ reliance on steroids, which are highly effective but often cause severe side effects.
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