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FDA Extends Review for Rare Kidney Drug
14 Jan
Summary
- FDA extended review for Travere's FSGS drug, decision now April 13.
- Travere shares fell nearly 20% following the announcement.
- The drug, Sparsentan, is already approved for IgA nephropathy.
The U.S. Food and Drug Administration (FDA) has extended its review for Travere Therapeutics' drug, Sparsentan, targeting a rare kidney disorder. The agency's decision on the expanded use for focal segmental glomerulosclerosis (FSGS) is now anticipated by April 13, 2026. This extension prompted a nearly 20% decrease in Travere's stock price.
Travere Therapeutics confirmed it had addressed the FDA's request for additional data concerning the drug's clinical benefit. Importantly, the company noted that no further information regarding the drug's safety or manufacturing processes was sought. CEO Eric Dube expressed commitment to bringing the medicine to patients with this severe disease.
Sparsentan, marketed as Filspari, is already authorized to slow kidney function decline in adults with IgA nephropathy. In a late-stage FSGS study, Sparsentan demonstrated a significant reduction in protein levels in urine compared to irbesartan. The drug functions by blocking two key receptors to protect kidney cells and slow progression.
