July 24 (Reuters) – 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.
Here are some details:
• 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.
(Reporting by Kunal Das in Bengaluru; Editing by Sahal Muhammed)
Comments