Key Takeaways:
- Amgen hired Duke Clinical Research Institute to independently review Tavneos data
- FDA proposed withdrawing the drug in April, citing efficacy and safety concerns
- Amgen must submit its findings to the FDA by June 29
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Amgen hires Duke to review Tavneos data after FDA withdrawal threat
Amgen Inc. has enlisted the Duke Clinical Research Institute to independently review clinical data for its rare-disease drug Tavneos (avacopan) after the U.S. Food and Drug Administration proposed withdrawing the medicine from the market over safety and efficacy concerns.
"An independent, blinded review of the primary endpoint results from the ADVOCATE study began in February," Amgen said in a letter dated June 1 and posted in the agency's records. The company plans to submit detailed data to the FDA by June 29.
The FDA in April proposed withdrawing Tavneos' approval, citing a lack of proven effectiveness and what it called false statements in the original application. A month earlier, the agency flagged 76 cases of drug-induced liver injury with evidence suggesting a causal link to the drug, including eight deaths. About 20 additional deaths linked to serious liver dysfunction have been reported in Japan among patients treated with Tavneos, according to a May safety notice from partner Kissei Pharmaceutical.
Tavneos was approved in October 2021 to treat severe active ANCA-associated vasculitis, a rare autoimmune disease that inflames small blood vessels and can damage organs including the kidneys and lungs. Amgen acquired the drug through its $3.7 billion purchase of ChemoCentryx in 2022. The company said it believes Tavneos' benefits outweigh its risks and that withdrawing the drug would not be in the best interest of patients.
The outcome of the FDA review carries significant financial implications for Amgen, which has a market capitalization of about $197 billion and trades at 24.6 times earnings. If Tavneos is withdrawn, the company would lose a revenue-generating asset in its rare-disease portfolio, which it expanded last year through the acquisition of Horizon Therapeutics. Investors will watch for the FDA's decision after Amgen's June 29 data submission, as the agency weighs the independent review findings against the mounting safety signals.
This article is for informational purposes only and does not constitute investment advice.
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