Renalys Pharma, Inc., a late-stage clinical biopharmaceutical company announces that sparsentan, in-licensed from Travere Therapeutics, Inc. (“Travere”) and currently in phase III clinical trials in Japan, has received Orphan Drug Designation from the Japanese Ministry of Health, Labour and Welfare for the indication of primary IgA nephropathy as of November 27, 2024.
Orphan disease drugs are designated by the Minister of Health, Labour and Welfare for conditions with fewer than 50,000 eligible patients in Japan and recognized high unmet medical needs. Orphan Drug Designation is subject to priority review, which is expected to shorten the approval process for Marketing Authorization by several months.
“IgA nephropathy, a leading cause of kidney failure, occurs when abnormal IgA proteins deposit in kidney tissue, leading to inhibited kidney function and inflammation. There is an extremely high unmet medical need in Japan, as no approved drugs are currently indicated for this disease,” said Ryutaro Shimazaki, Chief Development Officer of Renalys Pharma. “We have in-licensed the Japan and Asian rights to sparsentan, which has already received approval in Europe and the United States and are advancing clinical development leveraging the global phase III PROTECT data in order to address the kidney function loss in this disease. Orphan Drug Designation for sparsentan has now been granted, further shortening the development time in Japan. We will continue to work with all parties involved to bring this breakthrough drug to patients with IgA nephropathy as soon as possible.”
Sparsentan was developed by Travere, and Renalys Pharma holds an exclusive license for its development and commercialization in Japan, South Korea, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. In September 2024, Travere received full FDA approval for sparsentan (U.S. brand name: FILSPARI®) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
Renalys Pharma is committed to advancing its business to contribute to improving the lives of patients in Japan and Asia by developing innovative therapies for kidney disease, with a primary focus on delivering sparsentan to patients as soon as possible.
