Amgen Seeks FDA Hearing, Files New Data to Prevent Tavneos Market Withdrawal
Bengaluru: Amgen said on Friday it submitted new evidence to the FDA on July 23 as it seeks a hearing to challenge the proposed withdrawal of its rare-disease drug Tavneos from the U.S. market.
The U.S. Food and Drug Administration in April proposed withdrawing the drug, which treats a rare autoimmune disease that damages blood vessels, citing a lack of proven effectiveness and false statements in its original marketing application.
Amgen said it strongly disagrees with the FDA and that its submission includes more than 70 real-world studies involving over 2,200 patients supporting the drug's effectiveness and safety.
The drugmaker said the Duke Clinical Research Institute, which it had commissioned to independently review the pivotal trial, found Tavneos matched a steroid treatment regimen at 26 and 52 weeks, although the review did not reproduce the original finding of superiority at 52 weeks.
The health regulator in March had separately identified 76 cases of serious liver injury linked to Tavneos, including eight deaths and seven cases of a rare condition that can cause permanent liver damage.
In June, Europe's drug regulator recommended revoking the drug's approval, citing unreliable study data.
Tavneos treats severe active ANCA-associated vasculitis, a rare disease that inflames blood vessels and can damage organs including the kidneys and lungs.
Amgen has until July 29 to submit all data, information and analyses in support of a hearing, an FDA official told Reuters on Friday.
The FDA said in April that Tavneos would remain on the U.S. market unless Amgen removes it or the FDA commissioner orders its withdrawal.
