FDA moves to withdraw Tavneos over efficacy and safety concerns
BROBROK News · Based on reporting by DiarioBitcoin ·
The FDA has proposed pulling Tavneos from the market after questioning the strength of its clinical evidence and citing reports of serious liver injury, including fatal cases. Amgen disputes the move, and the drug remains available while the regulatory process continues.
Key points
- The FDA says Tavneos lacks substantial evidence of effectiveness.
- The agency cites reports of severe liver injury, including deaths.
- The dispute centers on the trial data used for the 2021 approval.
- The FDA says ChemoCentryx rechecked some data without informing regulators.
- Tavneos stays on the market unless the company or FDA removes it.
Why it matters
The decision could affect patients with ANCA-associated vasculitis who use Tavneos to reduce reliance on steroids. It also underscores how post-approval scrutiny can reshape the outlook for a drug that had already become a major product.
Original headline: “La FDA busca retirar Tavneos tras dudas sobre datos clínicos y seguridad”
Read the original on DiarioBitcoin
Summary and analysis written by BROBROK News from the original report. Read the full story on the source website. Not investment advice.