In this Healio video exclusive, Leonard H. Calabrese, DO, chief medical editor of Healio Rheumatology, highlights recent coverage regarding the FDA’s effort to revoke its approval of avacopan for ANCA-associated vasculitis.

The FDA has alleged that employees of the drug’s original manufacturer, ChemoCentryx, manipulated data in the ADVOCATE trial, which was the sole study the FDA considered before approving avacopan (Tavneos, Amgen) in 2021. The New England Journal of Medicine has since retracted its publication of the ADVOCATE trial at the request of the study’s academic authors.

“This is really important,” Calabrese said. “We have a lot of thought leaders weighing in on this, and you need to read this because this is serving a lot of our patients right now.”

Amgen, which acquired the drug in its 2022 purchase of ChemoCentryx, maintains that avacopan is effective and bears a favorable risk-benefit profile. The company has until July 29 to respond to the FDA. The drug remains on the market pending the hearing process.

Calabrese additionally discussed a recent study suggesting patients with systemic autoimmune rheumatic disease demonstrate an increased persistence of SARS-CoV-2 antigen positivity up to 6 months after COVID-19 infection.

“This is a very interesting article and some work by the group at Mass Brigham,” he said. “They show patients with autoimmune rheumatic diseases demonstrating persistence of COVID antigen positivity, and what the relationship that might be to long COVID complications.”

Leonard H. Calabrese, DO, can be reached at calabrl@ccf.org or at rheumatology@healio.com.