Drugs

Apellis Files Empaveli sNDA in Rare Kidney Diseases

FDA has accepted for priority review an Apellis Pharmaceuticals supplemental NDA for Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases. The agency has set a user fee review action target date of 7/28. “Empaveli demonstrated clinically meaningful benefits across all three key markers of disease — unprecedented proteinuria reductions, stabilization of kidney function, and substantial clearance of C3c staining,” a company release says.

C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure, according to Apellis. Excessive C3c deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure.

The submission is based on data from the company’s Phase 3 VALIANT study, which met its primary endpoint of demonstrating a statistically significant 68% proteinuria reduction in Empaveli-treated patients compared to placebo, according to the company. Also, Empaveli-treated patients achieved stabilization of kidney function, and a substantial proportion of Empaveli-treated patients achieved a reduction in C3c staining intensity, it says.

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