Filspari Granted Accelerated Approval to Reduce Proteinuria in IgA Nephropathy
Sparsentan is an endothelin and angiotensin II receptor antagonist.
Sparsentan is an endothelin and angiotensin II receptor antagonist.
The target action dates have been extended by 3 months to allow for extra time to review the applications.
The approval was based on data from the phase 3 ILLUMINATE-C study that included 21 dialysis-independent and -dependent patients with PH1.
The FDA has approved Kyzatrex (testosterone undecanoate) for the treatment of primary and secondary hypogonadism in adult males.
The Biologics License Application (BLA) for Vicineum included preliminary findings from the phase 3 VISTA trial.
In the CRL, the FDA stated that the application could not be approved in its present form and that an additional clinical trial would be required.
Cohort 3 of the phase 2 TROPHY-U-01 trial evaluated sacituzumab govitecan plus pembrolizumab in checkpoint inhibitor-naive adults with metastatic urothelial cancer who progressed after platinum-based chemotherapy.
The NDA submission included data from 36 clinical trials involving over 8000 patients.
The phase 3 LEAP-011 study evaluated pembrolizumab plus lenvatinib vs placebo in 441 adults with histologically confirmed, locally advanced or metastatic urothelial carcinoma.
The EMPA-KIDNEY study enrolled more than 6600 patients with CKD attributable to a wide range of underlying causes.