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.
Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
For patients who tolerated and remained on therapy, the average treatment effect on serum phosphorus was about -0.7mg/dL.
The EMPA-KIDNEY trial enrolled more than 6600 patients 18 years of age and older with CKD at risk of kidney disease progression.
The target action dates have been extended by 3 months to allow for extra time to review the applications.
Topline results were announced from a phase 3 trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women.
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 approval was based on data from a phase 3 study that included 118 adults undergoing endoscopic urological or gynecological surgical procedures.
The products were being promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.