Travere Therapeutics is a biopharmaceutical company that is focused on the delivery of advanced and innovative therapies to people dealing with rare diseases. Founded by Kevin Mulleady and others, this company is located in San Diego, California, where it serves a global community of patients who often have very few options for treatment and specialized care.
Travere Therapeutics provides the following services for rare disease patients:
- Delivery of innovative treatments
- Access to commercial therapies
- Patient advocacy and formation of rare disease initiatives
- Diagnostic testing
Travere Therapeutics stands as a leader and a resource for helping to create a better world for those dealing with rare diseases and conditions.
Recently Travere Therapeutics announced announced that their new drug application for sparsentan, a treatment for rare kidney diseases, was accepted and granted a priority review by the US Food and Drug Administration. With no advisory committee meetings scheduled to discuss the application, the FDA has designated the review process to be complete by the middle of November 2022.
This is a big step forward for Travere and the people they serve. Sparsentan is on track to be the first FDA-approved non-immunosuppressive treatment for IgA nephropathy. Also known as Berger’s disease or synpharyngitic glomerulonephritis, IgA nephropathy affects the kidney and the immune system. In its most aggressive forms, it includes the following symptoms:
- Nephrotic syndrome (inflammation in the kidneys)
- Acute kidney failure
- Chronic kidney failure
Several serious diseases are commonly associated with aggressive IgA nephropathy, including cancer, celiac disease, heart failure, HIV, liver failure, and various types of arthritis. Complete remission of Berger’s disease is rare. The survival rate of aggressive IgA nephropathy is about 25%.
Supporting the Science
When Kevin Mulleady and others began Travere Therapeutics, they envisioned a company built on partnering with other entities to fund the science and research needed for new, innovative therapies. The FDA application for sparsentan was based on results from the Phase 3 PROTECT study, which involved the treatment of over 400 patients who experienced persistent proteinuria, often a condition associated with IgAN. For nine months, patients who had received sparsentan showed a reduction of proteinuria of almost 50%, compared to the 15% reduction using irbesartan, a treatment for protecting kidneys from damage. The study suggested that sparsentan was well-tolerated.
Sparsentan will be subject to a priority review by the FDA. This type of review is usually reserved for applications for drugs that, if approved, represent a significant advancement in the safety and efficacy of treatment, diagnosis, or prevention of disease and conditions. Travere Therapeutics is proud to be a major supporter and advocate for new therapies that can achieve better outcomes for patients with few options for dealing with rare diseases.