CDER proposes to withdraw approval of Tavneos

Yesterday, the Center for Drug Evaluation and Research proposed that Tavneos be withdrawn from the market because new information indicates that Tavneos has not been shown to be effective for its approved use, and because the application that resulted in FDA approval contained untrue statements of material fact. Once this proposal is published in the Federal Register, this webpage will be updated with a link to the docket where interested persons may view supporting materials and submit comments, the FDA stated. “As explained in the proposal to withdraw approval of TAVNEOS, new information that only became known to CDER more than three years after approval shows that unblinded study personnel manipulated the results of the pivotal clinical study so the drug looked effective when the original analysis did not support that conclusion. The applicant also did not disclose the original analysis to FDA, in violation of FDA regulations. CDER can no longer conclude that there is, or has ever been, a valid demonstration that TAVNEOS is effective for its approved use. Therefore, CDER has proposed that TAVNEOS be withdrawn from the market and has issued a notice of opportunity for a hearing (NOOH) to the application holder of TAVNEOS, ChemoCentryx Inc., a wholly owned subsidiary of Amgen (AMGN),” the FDA stated.