Travere Therapeutics Inc. (NASDAQ: TVTX) has submitted a New Drug Application to the FDA for accelerated clearance for sparsentan under Subpart h for IgA nephropathy treatment.
Travere submits NDA for sparsentan for proteinuria treatment
CEO Eric Dube said, “There is a clear need for novel treatment options that can reduce proteinuria and slow the devastating progression towards end-stage kidney disease for people living with IgA nephropathy. The submission of this NDA marks an important milestone on our path to potentially making sparsentan, if approved, a new treatment standard for the rare kidney disease community, and we look forward to working with the FDA during the upcoming review process.”
Positive preliminary results from the continuing crucial Phase III PROTECT Study, a worldwide, randomized, controlled trial evaluating the efficacy and safety of sparsentan in 404 subjects with IgAN, and also findings from more clinical trials and preclinical screening of sparsentan, support the NDA submission. The study evaluated 400mg sparsentan relative to 300mg irbesartan in adult patients with IgAN and proteinuria. Traveres anticipates receiving notification from the FDA regarding the approval of the NDA, and the timeframe for NDA review, in May 2022.
IgA Nephropathy characterized by immunoglobin A buildup
IgA nephropathy, also called Berger’s disease, is a rare kidney condition characterized by immunoglobulin A buildup. IgA is a protein that helps in fighting against infections in the kidneys. However, the IgA deposits can lead to a breakdown in the kidney’s conventional filtering mechanisms that result in proteinuria (protein in the urine) and hematuria (blood in the urine). Some of the symptoms of IgAN might include blood pressure, kidney pain, and edema (swelling).
It is vital to note that IgAN is the commonest primary Type of glomerulonephritis global and the main cause of end-stage kidney diseases. It is estimated that IgAN affects close to 100,000 people in the US, and it is the main cause of acute nephritis in Japan and Europe. Currently, there is no cleared non-immunosuppressive therapy indicated for IgAN.
