FDA Grants FILSPARI Accelerated Approval for the Treatment of IgA Nephropathy in Adults

Today marks an incredibly promising day for the rare kidney disease (RKD) community: the FDA has announced that the drug FILSPARI (sparsentan) has been granted accelerated approval for the treatment of IgA nephropathy in adults.

The FDA’s accelerated approval program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need. FILSPARI has been granted accelerated approval based on reduction of proteinuria. It is not yet known if the drug slows kidney function decline in IgAN patients.

Over the next several months, Travere Therapeutics, the company that developed FILSPARI, will share more information about this new treatment and explain when and how those who need the drug can access it.

“This is the moment we’ve all been working toward. FILSPARI’s FDA approval for IgA nephropathy is monumental for the entire rare kidney disease community. Today marks the start of a new era for the treatment of RKD — it is a testament to the research community’s and Travere’s commitment to our patients,” said Josh Tarnoff, NephCure’s CEO.

“Our collective community is incredibly proud to reach this point, but we know the next phase of our vital work now begins: ensuring those who need this drug have access to it in time to save their kidneys. We’ve waited so many years for this treatment. Today’s FDA approval provides a beacon of hope that more needed new treatments are likely to be available soon.”

The continued approval of FILSPARI may be dependent upon the data from Travere’s ongoing phase 3 PROTECT study. This study evaluates the drug in more than 400 patients with persistent proteinuria. After 36 weeks of treatment, patients receiving the drug achieved a nearly 50% reduction in proteinuria.

While this is a new era for RKD patients and their families, we know that we still have a long way to go. FILSPARI is also being studied in FSGS patients, and it could be approved for the treatment of FSGS within the next year. With more than 60 clinical trial opportunities for RKD patients, even more new treatments are likely to be approved in the near future.

We celebrate today, but we know we have not crossed the finish line yet. We must keep pushing research forward so we can continue to improve health outcomes for RKD patients. As Josh mentioned, we’re now facing a new challenge — ensuring all patients have timely and equitable access to these new and better treatments.

We remain focused on our mission to empower people with rare, protein-spilling kidney disease to take charge of their health, while leading the revolution in research, new treatments, and care.

We thank you for your incredible support that has helped us get to this day, and we are grateful for your continued dedication to our mission.

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