Oral Steroid Safely Treats IgA Nephropathy: Trial Published
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Patients with immunoglobulin A (IgA) nephropathy showed clinically meaningful improvements in several measures of renal function after 9 months of treatment with a delayed-release formulation of the oral glucocorticoid budesonide, Nefecon, in a pivotal trial. The newly published findings "support Nefecon as the first disease-modifying therapy approved for patients with primary IgA nephropathy at risk of end-stage kidney disease," write Jonathan Barratt, MD, professor of renal medicine at the University of Leicester, UK, and co-authors in a recent report, which details part A of the NefIgArd trial, published in Kidney International.
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@firdaus The FDA gave this formulation of delayed-release budesonide an orphan-drug designation, as well as accelerated approval, which the agency says, "enables FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients.