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.
The regulator says Tavneos was approved on the basis of manipulated study data.
The short version
- Should patients still have access to it?
- 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.
What happened
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.
Why it matters
But according to the FDA, it was hard to interpret the results because the study’s design had been less than optimal.
Summary by Nerd News Network. Read the full article at Ars Technica via the links above and below.