FDA accepts, grants priority review of new treatment for IgA nephropathy
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Travere Therapeutics Inc. announced the FDA has accepted and granted priority review of its new drug application under subpart H for accelerated approval of sparsentan for treatment of IgA nephropathy.
According to the company press release, sparsentan is a dual endothelin angiotensin receptor antagonist that targets the endothelin A receptor and the angiotensin II subtype 1 receptor.
“For decades, people living with IgA nephropathy have had limited treatment options while facing a progression toward end-stage kidney disease. If approved, sparsentan would be the first FDA-approved non-immunosuppressive treatment option for IgA nephropathy, and we aspire to ultimately position sparsentan as a new standard of care,” Eric Dube, PhD, president and CEO of Travere Therapeutics, said in the release.
In the ongoing, phase 3 PROTECT study, researchers examined sparsentan in 404 patients with proteinuria to determine the effectiveness of treatment. After 36 weeks of treatment, researchers found sparsentan was well-tolerated and achieved a mean reduction in proteinuria from baseline of 49.8%.
The FDA assigned a Prescription Drug User Fee Act target action date of Nov. 17 for sparsentan.
“Acceptance of the NDA and being granted priority review brings us one step closer to potentially delivering sparsentan to the IgA nephropathy community before the end of this year, and we look forward to continuing to work with the FDA throughout the review process,” Dube concluded.
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