Drugs

Travere Therapeutics NDA Accepted for Sparsentan

FDA has accepted for priority review a Travere Therapeutics NDA for sparsentan and its use in treating IgA nephropathy (IgAN). The company says it is seeking accelerated approval, and, if approved, sparsentan would be the first FDA-approved non-immunosuppressive treatment option for IgA nephropathy. The agency has set an 11/17 user fee review action target date.

The submission is based on data from the ongoing Phase 3 PROTECT Study, which is evaluating 404 patients with persistent proteinuria. Travere says the study met its pre-specified interim primary efficacy endpoint measuring change in proteinuria compared to the active control, irbesartan. “After 36 weeks of treatment,” the company says, “patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a mean reduction in proteinuria from baseline of 15.1% for irbesartan-treated patients (p<0.0001).”

IgAN is also called Berger's disease, a rare kidney disorder characterized by the buildup of immunoglobulin in the kidneys, which causes a breakdown of the normal filtering mechanisms in the kidney that causes blood and protein in the urine, according to the company.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome