The FDA wants to pull its approval of a drug. It’s not so easy.
The regulator says Tavneos was approved on the basis of manipulated study data. Should patients still have access to it?
In May 2021, the US Food and Drug Administration (FDA) released a comprehensive briefing document regarding an experimental medication aimed at treating a rare autoimmune form of vasculitis, which can cause significant damage to kidneys and lungs. The agency was undecided about approving the treatment and sought input from an independent advisory committee.
The core question was whether the drug was significantly more effective than current therapies. Initial study results from the California biotech company ChemoCentryx showed that patients who took the drug had marginally higher rates of symptom remission after a year. However, the FDA found it challenging to draw meaningful conclusions due to the study's suboptimal design.
Some committee members agreed, stating that "the effect of the drug is just not well verified by this study." Despite this, many patients and physicians found the data promising, suggesting it could reduce the reliance on steroids, which are highly effective but often cause severe side effects.
Written by urgent.news from Ars Technica's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
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