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 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 […]
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FDA proposes to withdraw Amgen’s rare autoimmune disease drug
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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 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.
(Reporting by Natalia Bueno Rebolledo in Mexico City; Editing by Rashmi Aich)