The once-daily oral medication FILSPARI has been designed to target two critical pathways selectively in the disease progression of IgAN (endothelin-1 and angiotensin II).
It is said to be the first and only non-immunosuppressive therapy that has received approval to treat this condition.
FILSPARI is expected to be available beginning this month-end.
Ligand Pharmaceuticals CEO Todd Davis said: “We are delighted to see the approval of sparsentan, now FILSPARI, which represents a significant step forward in improving the lives of patients living with IgA nephropathy.
“Our partnership with Travere has been a remarkable journey, and we are proud to have played a part in bringing this innovative treatment to market. Congratulations to the entire team at Travere on this accomplishment.”
Under Ligand’s license deal with Travere for the therapy, Ligand will receive a net $15.3m milestone on the FDA approval.
It is also eligible for other potential milestones and 9% net royalties on future global net product sales of sparsentan.
Travere Therapeutics president and CEO Eric Dube said: “As a first-of-its-kind, non-immunosuppressive therapy, we believe FILSPARI has the potential to ultimately become the new standard of care for IgA nephropathy and offer hope to those living with this condition who until now have had few treatment options.
“We are grateful to the patients, caregivers, clinical trial investigators, healthcare providers, and advocates who have worked alongside us to develop this innovative first-in-class therapy.”
The FDA approval is based on clinically meaningful and statistically significant improvements in proteinuria against an active comparator in the pivotal and ongoing Phase III PROTECT Study.
IgAN is a rare kidney disease.