FDA Wants Drug Pulled From Market, Citing Liver Risk. Company Says No.

FDA Wants Drug Pulled From Market, Citing Liver Risk. Company Says No.

(MedPage Today) -- The FDA has requested that Amgen voluntarily withdraw avacopan (Tavneos), a treatment for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, but the company said it has no plans to pull the drug from the market...

Earnings roundup: Amgen vs. FDA, Pfizer’s defense and Merck’s $70B-in-sales plan

Amgen is refusing U.S. regulators’ request to withdraw an inflammatory disease drug. Elsewhere, Pfizer battled skepticism on new obesity drug data, and Merck laid out its post-Keytruda future.

FDA Wants Drug Pulled From Market, Citing Liver Risk. Company Says No

(MedPage Today) — The FDA has requested that Amgen voluntarily withdraw avacopan (Tavneos), a treatment for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, but the company said it has no plans to pull the drug from the market… Source link : https://www.medpagetoday.com/rheumatology/generalrheumatology/119741 Author : Publish date : 2026-02-04 21:29:00 Copyright for syndicated content belongs to the linked […] The post FDA …

Amgen Defies FDA Request to Withdraw Tavneos Amid Data Integrity Concerns

Amgen has rejected an FDA request to voluntarily withdraw its rare disease drug, Tavneos, following concerns over Phase 3 clinical trial data integrity and potential liver toxicity. While European regulators are also re-reviewing the drug, Amgen maintains that years of Real World Evidence and a lack of alternative treatments for ANCA-associated vasculitis justify keeping it on the market. The standoff involves a rapidly growing asset that genera…

Amgen says it doesn’t plan to pull its rare disease drug Tavneos, despite FDA ask

Several years of questions about Amgen's rare disease treatment Tavneos have come to a climax after the FDA asked the company to pull the drug from the market, and Amgen said it has no plans ...