ChemoCentryx Inc. (NASDAQ: CCXI) has announced the Japanese Ministry of Health, Labour, and Welfare approval of Kissei Pharmaceutical Co. Ltd, to market avacopan (TAVNEOS) for treatment of granulomatosis with polyangiitis and microscopic polyangiitis patients treatment.
Vifor Pharma commercializes avacopan outside the US
GPA and MPA are the main types of anti-neutrophil cytoplasmic autoantibody-related vasculitis, also called ANCA vasculitis or ANCA-associated vasculitis. The company’s Kidney Health Alliance and Vifor Pharma offer exclusive rights to Vifor Pharma for commercialization of avacopan outside the US. In addition, Vifor Pharma gave Kissei Pharmaceuticals exclusive license for the commercialization of avacopan in Japan.
The MHLW has declared ANCA-associated vasculitis to be an incurable condition. Intractable diseases don’t have an effective cure, but they require long-term care. Japan encourages research into incurable diseases and provides financial assistance to those suffering from these illnesses.
ChemoCentryx CEO and President Thomas Schall said, “This marks the first ever approval by a regulatory agency of a novel medication discovered and developed by ChemoCentryx. We would like to thank Kissei and the MHLW for their time and tremendous efforts, which made this important milestone in the mission to bring relief to patients suffering from diseases with major unmet needs possible.”
Avacopan treating ANCA-related vasculitis
The PDUFA date in other countries for the FDA decision on the mended NDA will be October 7, 2021, and the EU regulatory decision after the EMA review will be the end of this year.
Avacopan is an orally given small molecule employing proprietary, high-targeted action mode in complement-associated inflammatory and autoimmune diseases. The molecule blocks the C5aR for the pro-inflammatory complement system part called C5a.
ChemoCentryx is creating avacopan for C3 glomerulopathy (C3G), Lupus Nephritis (LN), and hidradenitis suppurativa (HS) treatment. Avacopan has an orphan drug by the US FDA for ANCA-associated vasculitis and C3G. In addition, the European Commission has designated avacopan as an orphan pharmaceutical product for the treatment of two ANCA-associated vasculitis forms.