Approval granted for first oral vasculitis treatment in Japan

pharmafile | September 27, 2021 | News story | Sales and Marketing  

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) has announced that Japan’s Ministry of Health and Labour Welfare (MHLW) has granted marketing approval for TAVNEOS® (avacopan), in the treatment of ANCA-associated vasculitis – a rare and severe autoimmune disease.

TAVNEOS, manufactured by Kissei Pharmaceutical Co Ltd, is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis in Japan – granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

The approval is based on the marketing authorisation application filed out by Kissei. The application showed positive clinical data from the Phase III trial ADVOCATE, in a total of 331 patients with MPA and GPA in 18 countries and regions, including Japan. According to Birmingham Vasculitis Activity Score (BVAS), TAVNEOS demonstrated superiority over standard of care at week 52.

With approximately 70 years of history, Kissei is dedicated to providing innovative pharmaceutical products to patients worldwide, as a strongly R&D-oriented corporation.

“ANCA-associated vasculitis is an intractable disease in Japan, meaning that although long-term treatment is required, there is little effective treatment currently available,” says Abbas Hussain, CEO of Vifor Pharma Group. “There is significant unmet medical need of over 10,000 patients in Japan, and we believe in the potential of TAVNEOS for treating it. We are confident that Kissei will  fully focus on bringing this breakthrough treatment to this patient population, helping them lead better, healthier lives.”

Kissei expects to begin to market TAVNEOS as soon as possible following NHI price listing. Outside Japan, TAVNEOS remains in regulatory review with various agencies, such as the FDA and EMA.

Lina Adams


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