Trial data 'can no longer be relied upon' to demonstrate drug's efficacy, EMA committee says
— Trial data "can no longer be relied upon" to demonstrate drug's efficacy, EMA committee says
by Ian Ingram, Managing Editor, MedPage Today
June 26, 2026
• 2 min read
A European Medicines Agency (EMA) committee recommended pulling the marketing authorization for avacopan (Tavneos) following a review over data integrity concerns in the vasculitis drug's key supporting trial.
The FDA has proposed to withdraw its approval of avacopan for ANCA-associated vasculitis, alleging that employees of the original…
EMA's CHMP recommends revoking Tavneos' marketing authorization over flawed clinical data, as US approval also hangs in the…
As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators…
The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing…
Amgen has asked the FDA to review evidence that its drug Tavneos (avacopan), which treats a rare form of vasculitis, is worth…
After the drug’s local license holder called for a brief pause in new patient starts last week, doctors in Japan can once again…
