Amgen Submits New Avacopan Data to FDA

Amgen submitted a third-party review of avacopan's (Tavneos) pivotal trial data and additional analyses to the U.S. Food and Drug Administration (FDA) this week. This move aims to preserve the drug's approval for treating severe anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The company is seeking to address concerns raised by the FDA regarding alleged data manipulation in the original trial.

The FDA had previously expressed concerns about the integrity of the data submitted for avacopan. These concerns prompted Amgen to commission an independent review of the existing data and conduct further analyses. The company stated that it is committed to transparency and is working closely with the FDA to resolve these issues. The drug, marketed as Tavneos, is a selective and reversible inhibitor of the complement component 5a receptor (C5aR).

Avacopan received accelerated approval from the FDA in October 2021 for adult patients with severe active ANCA-associated vasculitis. This approval was based on data from the ADVOCATE trial, which demonstrated that avacopan, in combination with standard immunosuppressive therapy, was superior to standard therapy alone in achieving disease remission. The drug's efficacy and safety profile are now under renewed scrutiny following the FDA's allegations. Amgen has not disclosed the specific findings of the third-party review but indicated that it provides a comprehensive re-evaluation of the trial's outcomes and data integrity.