ChemoCentryx Inc (NASDAQ:CCXI) recently revealed that it submitted a New Drug Application (NDA) for avacopan as an indication for ANCA-associated vasculitis.
The company attached clinical research findings from its ADVOCATE Phase 3 trial in which the pipeline treatment demonstrated a superior ability to sustain remission. The phase 3 trial evaluated avacopan’s performance against prednisone with patients in one group being treated with one while the second group was treated with the other. The study’s findings revealed that patients treated with avacopan yielded statistically superior results at 52-weeks compared to patients treated with prednisone.
The clinical trial findings also indicated that avacopan has a good safety and efficacy profile as a treatment for ANCA-Associated Vasculitis. There were fewer adverse effects in the patient group treated with avacopan than the group treated with prednisone.
“We have achieved a major landmark for ChemoCentryx with the submission of the NDA for avacopan in ANCA-associated vasculitis following our highly successful Phase III ADVOCATE trial,” stated ChemoCentryx CEO, Thomas J. Schall.
Dr. Schall also pointed out that ANCA-associated vasculitis patients urgently need a targeted therapy that does not suppress their immune system. The urgency also extends to the need for a treatment that can sustain remission against the life-threatening illness while avoiding the toxicity involved with the use of steroids regularly.
ChemoCentryx is optimistic that the data from the ADVOCATE Phase 3 trial will help support the NDA. It also helps that avacopan previously received orphan drug designation from the FDA and a similar European designation called orphan medicinal product designation from the European Commission. Vifor Fresenius Medical Care Renal Pharma (VFMCRP), ChemoCentryx’s marketing partner, has expressed interest in filing for a Marketing Authorization Application (MAA) from the European Medicines Agency.
VFMCRP plans to file for the MMA before the end of this year, which means that both companies are already making plans for avacopan’s commercial availability as soon as it receives regulatory approval. The MMA means that VFMCRP plans to handle commercial rights to avacopan in Europe as per their partnership agreement with ChemoCentryx. The latter owns the rights for avacopan’s discovery and development, and it will also own the exclusive commercial license for the treatment in the U.S.