A potential FDA approval for FILSPARI in FSGS by September 2025 could significantly expand its market reach, with the addressable patient population estimated at up to 30,000 in the U.S.

Learn about side effects, cost, uses, and more of Filspari (sparsentan), which is a prescription drug that helps manage IgA nephropathy in adults.

FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data showing long-term durable benefit on ...

FILSPARI should generally be avoided in patients with elevated aminotransferases (>3x ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be at ...

Company completed Type C meeting with FDA, aligning on its plan to submit an sNDA; submission expected around end of 1Q25. If approved, FILSPARI could be the first and only approved medicine ...

So far, Filspari’s launch has been going well. The drug brought in $27.1 million in sales in the second quarter of the year, coming 37% above the prior quarter and ahead of analysts’ consensus ...

After meeting with the FDA, Company to submit a supplemental New Drug Application (sNDA) to FDA in Q1 2024 for conversion of the existing U.S. accelerated approval of FILSPARI® (sparsentan) in ...

Since Filspari's trial data suggests it's superior to Irbesartan, its market might be larger in the long run. For context, Irbesartan's market is projected to grow to $2.9 billion by 2031.

Filspari, an endothelin and angiotensin II receptor antagonist, had previously received accelerated approval for IgA nephropathy based on clinical trial data indicating a reduction of proteinuria.

SAN DIEGO, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to FILSPARI ...

Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy ...