NEJM retracts Tavneos trial, raising pressure on Amgen

Regulation Impact 4
โดย GuruFocus·Read original
Summary · why it matters

The New England Journal of Medicine has retracted the 2021 clinical trial that supported approval of Amgen's ANCA-associated vasculitis drug Tavneos. The retraction came after two study authors requested it, following an FDA investigation that found results from nine patients were changed after the study database was finalized and some researchers had been unblinded. The FDA has alleged that the original data did not show a statistically significant remission difference between Tavneos and other treatments, and has proposed withdrawing the drug from the market. European regulators have also proposed pulling the drug based on the same study, while CSL, which sells Tavneos in Europe under a license from ChemoCentryx, will not offer it to new patients. Amgen acquired ChemoCentryx for $3.7 billion in 2022 and continues to sell Tavneos in the US, where it generated $459 million last year, and has requested a hearing to contest the FDA's action.

Impact on stocks 1

Biotech & Genomic Medicine · 1 stocks
Amgen Inc
AMGN
▼ NegativeRegulationrelevance

NEJM retraction and FDA proposal to withdraw Tavneos due to data integrity issues.

Theme Impact 1

Off-coverage companies 1

CSL LimitedPrivate▼ Negative
Regulationrelevance

European regulators propose pulling Tavneos; CSL will not offer it to new patients.

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