FDA proposes to withdraw Amgen's rare autoimmune disease drug

The FDA's Center for Drug Evaluation and Research proposed withdrawing approval of an Amgen drug for rare autoimmune diseases, citing lack of proven effectiveness and untrue statements in the approval application. The action raises meaningful regulatory and legal risk for Amgen and could jeopardize sales tied to the product. The news is likely to pressure the stock and weigh on investor confidence in the franchise.

Analysis

The FDA's Center for Drug Evaluation and Research proposed withdrawing approval of an Amgen drug for rare autoimmune diseases, citing lack of proven effectiveness and untrue statements in the approval application. The action raises meaningful regulatory and legal risk for Amgen and could jeopardize sales tied to the product. The news is likely to pressure the stock and weigh on investor confidence in the franchise.