Amgen has submitted new evidence to the FDA to challenge the proposed withdrawal of its rare-disease drug Tavneos from the U.S. market. The U.S. Food and Drug Administration proposed withdrawing the drug in April, citing a lack of proven effectiveness and false statements in its original marketing application.
Tavneos Treats Rare Autoimmune Disease
Tavneos treats severe active ANCA-associated vasculitis, a rare disease that inflames blood vessels and can damage organs including the kidneys and lungs. Amgen strongly disagrees with the FDA and says its submission includes more than 70 real-world studies involving over 2,200 patients supporting the drug’s effectiveness and safety.
The Duke Clinical Research Institute, which Amgen commissioned to independently review the pivotal trial, found Tavneos matched a steroid treatment regimen at 26 and 52 weeks, although it did not reproduce the original finding of superiority at 52 weeks. The FDA did not immediately respond to a request for comment.
In March, the health regulator 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.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
