The US Food and Drug
Administration’s Center for Drug Evaluation and Research (CDER)
has proposed withdrawing approval of Amgen’s drug for
rare autoimmune diseases, citing a lack of proven effectiveness
and false statements in its original application.
In March, the agency 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.
A senior official at the CDER, which regulates prescription
and over-the-counter medicines, said in a letter to Amgen on
Monday that the agency can no longer conclude that “there is, or
has ever been, a valid demonstration of substantial evidence of
effectiveness for TAVNEOS.”
In the letter, CDER proposed to withdraw the drug “because
of new information, which was withheld from FDA and did not
become known to FDA until more than three years after approval,
indicating that there is a lack of substantial evidence of
effectiveness for the drug, and the application contains untrue
statements of material facts.”
Amgen did not immediately respond to a Reuters request for
comment outside regular business hours.
Tavneos, approved in October 2021, treats anti-neutrophil
cytoplasmic autoantibody (ANCA)-associated vasculitis, a rare
group of autoimmune diseases that cause inflammation in small-
to medium-sized blood vessels.
The FDA had previously asked Amgen to voluntarily withdraw
the drug from the US market amid concerns about trial data, a
request the company declined. At the time, Amgen said it was not
aware of any problems with the underlying patient data, remained
confident in Tavneos’ benefit-risk profile, and was working with
the FDA on next steps.
Tavneos will remain on the market unless Amgen withdraws it
or the FDA commissioner orders its removal, the agency said. In
the meantime, the FDA advised healthcare professionals to
discuss Tavneos and alternative treatment options with patients
while a final decision on the drug’s marketing status is
pending.