FDA proposes to withdraw Amgen’s rare autoimmune disease drug

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)