ChemoCentryx has just announced that they have submitted their New Drug Application to the FDA for a novel ANCA-associated vasculitis therapy. It is called avacopan and it’s finally something non-steroidal.
Typical treatment for this condition involves steroid use. This new drug is non-immunosuppressive, reduces the toxicities that come with steroid use, and has been shown to foster remission for patients. This remission is not only achieved but sustained.
This therapy has already been granted Orphan Drug Designation by the FDA and European Commission. The Marketing Authorization Application for the treatment should be submitted to the EMA before the end of this year.
The progress on this marketing authorization process is based on the ADVOCATE trial.
The ADVOCATE Trial
The ADVOCATE clinical trial was a Phase 3 investigation which aimed to examine avacopan treatment compared to prednisone treatment in ANCA-associated vasculitis patents. Avacopan is an oral treatment that works by prohibiting inflammatory cells from doing damage while ensuring beneficial pathways still function as they should.
The trial took place in 20 countries for 52 weeks and included 331 patients.
The patients who were randomized to receive avacopan had achieved remission with statistical superiority than the group on steroids, and this result was sustained. Additionally this group had-
- Lower glucorticoid toxicity
- Improved kidney function
- Improved quality of life
- Positive safety results
- Fewer adverse events
Current steroid use in this disease is associated with a significant risk of infection and death. The new therapy could be life-changing for this patient population.
In addition to vascultis, ChemoCentryx is also developing this therapy as a potential treatment for hidradenitis suppurativa (HS) and C3 glomerulopathy (C3G).
Hopefully, we will hear further updates on this investigative therapy soon.
You can read more about this treatment here.