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?
On May 2021, the US Food and Drug Administration (FDA) released an extensive briefing document concerning an experimental medication for a rare autoimmune form of vasculitis, which frequently harms the kidneys and lungs. The FDA was uncertain about approving the treatment and sought the input of an independent advisory committee.
Among the key concerns were whether the drug provided a significant improvement over existing therapies. The participants in the study, conducted by California biotechnology company ChemoCentryx, showed slightly higher rates of symptom remission after one year. However, the FDA found it challenging to interpret the results due to the suboptimal study design.
Some members of the advisory committee shared this view, stating that the drug's effect was not well-verified by the study. Despite this, many patients and some physicians perceived the data as presenting a potentially beneficial medication that could reduce patients' reliance on steroids, which are effective but often cause severe side effects.
Written by urgent.news from Ars Technica Science's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
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