Why I’m urging the FDA to maintain its approval of Tavneos

Note: This column describes the author’s own experiences with, or observations of, several medications. Not everyone will have the same response to treatment. Consult your doctor before starting or stopping a therapy.

I have eosinophilic granulomatosis with polyangiitis (EGPA), a type of ANCA-associated vasculitis (AAV) that is not indicated for the oral therapy Tavneos (avacopan), which is approved for the other two forms of AAV — microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA). Since EGPA was not a part of the drug’s clinical trials, those of us who have that type aren’t included in the drug’s label and indication.

Last April, the U.S. Food and Drug Administration (FDA) proposed withdrawing Tavneos from the market over questions about the drug’s effectiveness. Although I have no personal stake in the matter, I wrote the agency a letter asking officials not to do so. In my opinion, every treatment that can be used for AAV is important.

Currently, the FDA is accepting public comments before it makes a final decision.

Recommended Reading

May 13, 2026 News by Margarida Maia, PhD

Antibody type in AAV may help guide treatment for lung care, per study

Share your thoughts

In my view, Tavneos has allowed many of my AAV friends to taper down from high-dose steroids or go off them completely. This is something all of us patients long for. So my message to the FDA is based on a simple premise: When you live with something rare, you can’t afford to lose a single treatment. Our shelf, so to speak, is already bare.

I’ve been treated with azathioprine, mycophenolate mofetil, methotrexate, and rituximab. Each of them asked something of me and carried its own risks, such as infections, hypoxia that triggers hippocampal atrophy, liver toxicity, organ strain, and other quiet damage that builds while a drug is busy keeping us alive.

And then there’s prednisone, a drug many of us know all too well. It’s available, it’s cheap, and it works, but over time, it can cause excessive weight gain and mood changes, and might also affect bones, blood sugar, eyes, sleep, and the sense of who one is. It’s brutal.

That’s the trade-off we make — not because we want to, but because the disease doesn’t give us the option of doing nothing.

So when a treatment comes along that lets a patient taper off steroids, protecting their kidneys and giving back something closer to life in the process, I don’t think you should just throw it away.

I remember being in awe when I read about some people’s experiences with Tavneos. My friend Laure Larkin shared her experience with it on the Rare Candor podcast. Hearing her talk about going from 80 mg of prednisone to none in three months brought tears to my eyes. She also shared her experience on the FDA’s comments page.

The FDA’s public comment period is open until June 29. If you or someone you love has this disease, your voice is valuable. You don’t need to be a doctor or a policy expert. You just have to tell the truth about what treatments mean to you.

Note: ANCA Vasculitis News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of ANCA Vasculitis News or its parent company, Bionews, and are intended to spark discussion about issues pertaining to ANCA vasculitis.