Retrophin says plans Phase 3 trial before sparsentan regulatory filing
Retrophin provided an update on the regulatory pathway for its late-stage product candidate sparsentan: "Following guidance received from the FDA during the company's End of Phase 2 meeting, the company plans to initiate a single Phase 3 clinical trial to enable a New Drug Application filing for sparsentan for the treatment of focal segmental glomerulosclerosis. Notably, the trial will include an interim analysis of proteinuria as a surrogate endpoint to serve as the basis for an NDA filing for Subpart H accelerated approval of sparsentan. The confirmatory endpoint of the study will subsequently compare changes from baseline in estimated glomerular filtration rate, or eGFR. The company is working with the FDA to finalize the study protocol and expects to initiate the trial in 2H17."