US — Ars Technica

The FDA wants to pull its approval of a drug. It’s not so easy.

PolicyOctober 31, 20262 min read

The US Food and Drug Administration (FDA) now wants to take back its approval of Tavneos, a drug for a rare kidney and lung disease. The agency says the drug may no longer be proven to work and may harm the liver.

What happened

In 2021, the FDA approved Tavneos. It treats a rare autoimmune disease called vasculitis, which can damage the kidneys and lungs. Some experts doubted the test results were strong enough, but the FDA approved the drug anyway. In April of this year, the FDA proposed removing Tavneos from the US market. It cited reports of serious liver injury, some of them fatal, and said the drug no longer has "substantial evidence" that it works.

Key numbers and facts

The FDA approved Tavneos on October 7, 2021.
The drug costs about $220,000 per year, according to Drugs.com.
Sales of Tavneos reached nearly half a billion dollars in fiscal year 2025.
Amgen bought ChemoCentryx, the drug's developer, one year after approval.

Why the approval was debated

The drug was tested in a study run by ChemoCentryx, a California biotech company. Patients had slightly higher rates of symptom remission after one year. But the FDA said the study design was less than ideal, so the results were hard to read. Many patients and doctors still hoped the drug could reduce the need for steroids, which work well but can cause serious side effects. The advisory committee voted narrowly in favor of approval.

Why it matters

The FDA is now questioning a drug that people already use and pay a lot for. An investor lawsuit also found what the FDA believes is evidence that ChemoCentryx employees changed data in the key trial. If the FDA removes the drug, patients who rely on it may need to switch treatments. The case also shows how important reliable test data is for approving medicines.

What to watch

Whether the FDA formally withdraws Tavneos from the US market.
How Amgen, which owns ChemoCentryx, responds to the FDA's concerns.
Further reports on liver injury linked to the drug.
The outcome of the investor lawsuit and any findings about the trial data.

Glossary

FDA: The US government agency that checks whether medicines are safe and work before they can be sold.
ChemoCentryx: A California biotech company that developed Tavneos.
Amgen: A large pharmaceutical company that bought ChemoCentryx a year after Tavneos was approved.
Tavneos: The brand name of the drug used to treat a rare autoimmune form of vasculitis.

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