April 27 (Reuters) - The U.S. Food and Drug
Administration's Center for Drug Evaluation and Research on
Monday proposed withdrawing approval of Amgen's ( AMGN ) drug
for a group of rare autoimmune diseases, citing a lack of proven
effectiveness and untrue statements in the application that led
to its approval.
In March, the FDA said it identified 76 cases of drug-induced
liver injury with evidence suggesting a causal link to Tavneos,
including seven cases of vanishing bile duct syndrome (VBDS), a
rare condition that can cause permanent liver damage. Eight
deaths were reported among those cases.