Sparsentan receives Orphan Drug Designation for primary IgA nephropathy in Japan

TOKYO, Dec. 2, 2024 /PRNewswire/ -- 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.

About IgA Nephropathy

The management of patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD) has become a social issue that places a heavy burden on the Japanese healthcare system. IgA nephropathy is widely known as one of the main causes of kidney failure and is considered to develop when abnormal IgA proteins are deposited in kidney tissue, inhibiting kidney function and causing inflammation. IgA nephropathy is a rare intractable disease (designated as an intractable disease 66) with many unresolved mechanisms of onset and severity. Currently, there is a lack of treatment for IgA nephropathy and an unmet need for such treatment in Japan.

About Renalys Pharma, Inc.

Renalys Pharma, a privately held late-stage clinical biopharmaceutical company based in Japan, is committed to the development of multiple innovative therapeutics targeting unmet needs in the management of renal disease for Japanese and Asian patients. Founded by Catalys Pacific and SR One in 2023, the company aims to address the growing problem of "drug loss" by catalyzing access to new treatments for kidney disease patients in Japan and other Asian regions.

Company Name: Renalys Pharma, Inc.
Address: 3-11, Nihonbashi-honcho 2-chome, Chuo-ku, Tokyo, Japan
Representative: BT Slingsby, MD, PhD, MPH
Established: April 2023
URL: https://renalys.com/

Disclaimer

Information concerning pharmaceutical products (compound under development) contained herein is not intended as advertising or as medical advice, but intended for disclosure of management information.

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SOURCE Renalys Pharma, Inc.