FDA says trial manipulation undermines approval of ChemoCentryx's Tavneos, now owned by Amgen

The U.S. Food and Drug Administration has announced that it believes the pivotal trial supporting the approval of Tavneos was manipulated.

The agency says ChemoCentryx, which was acquired by Amgen, altered data from the study that formed the basis of the drug’s market authorization.

As a result, the FDA is intensifying its effort to withdraw Tavneos from the market while it reviews the new information.

The allegation raises concerns about the integrity of the approval process and could have broader implications for other products that rely on similar data.