Posted by Michael Wonder on 12 Mar 2024
Travere Therapeutics submits supplemental new drug application to the US FDA seeking full approval of Filspari (sparsentan) for the treatment of IgA nephropathy
11 March 2024 - Submission is based on 2 year confirmatory results from the Phase 3 PROTECT study in which Filspari demonstrated a significant reduction in proteinuria, preservation of kidney function and a generally well-tolerated safety profile compared with active control irbesartan.
Travere Therapeutics today announced the submission of a supplemental new drug application to the US FDA for conversion of the existing US accelerated approval of Filspari (sparsentan) in IgA nephropathy to full approval.
