In August 2026, the European Commission revoked the EU marketing authorisation of Tavneos (avacopan), marketed in Europe by CSL Vifor, following the recommendation of the European Medicines Agency (EMA). Avacopan was the first medicine approved to help reduce steroid use in GPA and MPA.
Many patients now ask: is anyone else working on this?
The answer is yes. Several companies are testing medicines that act on the complement system, the same part of the immune system that avacopan targeted.
What is in development
- Iptacopan (Novartis), a tablet that acts earlier in the complement system. A Phase 2 trial in GPA and MPA tests it with rituximab and a fast reduction of steroids. Results are expected after the end of 2026.
- Vilobelimab (InflaRx), an antibody given by infusion that blocks C5a. Two Phase 2 studies have been completed. The company has said it will discuss the route to approval with EMA.
- Izicopan (InflaRx), a tablet that blocks the C5a receptor, the same target as avacopan. A Phase 2 trial is being planned.
- BDB-001 (Staidson, China), an antibody similar to vilobelimab, is in a Phase 3 trial in China.
Note from the author: This overview is based on public sources and is not the result of a full search. It may not be complete. If you know of other relevant studies, please let us know.
And EGPA ?
The situation is different for EGPA. Avacopan was never approved for EGPA. Two medicines that target eosinophils, mepolizumab (Nucala) and benralizumab (Fasenra), are already approved in the EU and can help patients with relapsing or refractory EGPA reduce or stop their steroids.
What this means
None of these medicines is approved for GPA or MPA, and it will likely take several years before any of them reaches patients. Each must first prove its benefit and safety in larger trials.
Reducing steroids matters greatly to patients. Weight gain, sleep and mood problems, bone loss, diabetes and infections are part of daily life for many people on high doses. This is why Vasculitis International follows every step towards treatment with fewer steroids so closely.
We do not recommend any medicine. We ask that future trials have independent oversight of their data, involve patients in their design, and report safety openly. We will share reliable updates with our member organisations.
Transparency statement
Vasculitis International is largely funded by grants from pharmaceutical companies. Current and past funders include CSL Vifor, Novartis, Boehringer Ingelheim and InflaRx. The patient organisations Vasculitis UK, Vasculitis Ireland Awareness (VIA) and Vasculitis Stichting (NL) helped us start, and patient representatives donated their own fees to VI. Our funders have no say over what we publish or the positions we take.