Cases Include Tavneos Drug-Induced Liver Injury (DILI), Tavneos Deaths, Liver Side Effects

(Posted by Tom Lamb at Drug Injury Watch)

Observers in the drug injury and pharmaceutical safety sectors have been watching for a possible Tavneos recall since the FDA alerted doctors and patients about reports of serious liver injury associated with Tavneos, some of which resulted in deaths, last month. (For the details, see our 3/31/26 post, “Tavneos Liver Injury Drug Safety Communication Issued by FDA in Late March 2026 — Just 2 Months Earlier, Amgen Refused an FDA Request to Withdraw Tavneos; Will There Be a Tavneos Recall Soon?”) In turn, there may be Tavneos lawsuits that would include patients who developed serious liver side effects, such as Tavneos drug-induced liver injury (DILI), and Tavneos deaths.

Adding to the likelihood of a Tavneos recall and Tavneos lawsuits filed by patients against the drug manufacturer Amgen is that Tavneos is under review in Europe over concerns about the clinical data used to secure its approval there. From this European Medicines Agency (EMA) January 30, 2026 news release, “EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA“, we get the following information:

EMA’s human medicines committee (CHMP) has started a review of Tavneos (avacopan), following emerging information that raises questions regarding the data integrity of the Advocate study, which was the main study supporting the medicine’s marketing authorisation in the European Union. [For background, see “A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis (ADVOCATE)” page on the ClinicalTrials.gov website.]

Tavneos was authorised in the [European Union (EU)] in January 2022 for treating adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two rare inflammatory conditions of the blood vessels.

In the Advocate study, which included 331 patients with GPA or MPA, Tavneos was compared with high-dose corticosteroids (medicines used to treat inflammatory diseases), both in addition to standard treatment (either rituximab or a regimen consisting of cyclophosphamide followed by azathioprine). Based on data from this study, Tavneos was found to be at least as effective as high-dose corticosteroids in inducing remission in patients with GPA or MPA and to lead to better long-term remission rates.

The concerns relate to how the data for the Advocate study was handled before Tavneos was authorised, which may have impacted the findings on the medicine’s effectiveness.

EMA will now review all available data to assess whether this emerging information has an impact on the balance of benefits and risks of Tavneos. The Agency will then issue a recommendation on whether the marketing authorisation in the EU should be maintained, amended, suspended or revoked.

We are investigating Tavneos lawsuits for drug injury that include Tavneos drug-induced liver injury (DILI) and Tavneos side-effect cases of vanishing bile duct syndrome (VBDS), as well as Tavneos deaths. These Tavneos lawsuits would be filed on behalf of patients who developed these serious liver side effects as personal injury claims, and on behalf of families who may have wrongful death claims involving Tavneos patients who died. Both these types of Tavneos lawsuits would be filed against Amgen, as the responsible drug company.

If you have a possible Tavneos injury claim or Tavneos death claim that you want reviewed as a lawsuit filed against Amgen, you can submit a Drug Injury Case Evaluation Form online, send an email to drug injury lawyer Tom Lamb at TJL@LambLawOffice.com, or call us at 910-256-2971.

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