The U.S. Food and Drug Administration (FDA) has approved budesonide (Tarpeyo) to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy. This is the first and only FDA approved drug indicated specifically for the management of IgA nephropathy.
IgA nephropathy, also known as Berger’s disease, is a rare kidney disease characterized by the accumulation of IgA deposits in the kidneys. This buildup damages the glomeruli, causing hematuria and proteinuria. Eventually, IgA nephropathy can lead to end-stage kidney disease.
The approval was largely based on positive data from Part A of the phase 3 NefIgArd study. This is an ongoing randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of budesonide (16 mg once daily) compared to placebo in adult patients with primary IgA nephropathy.
Patients taking budesonide showed a statistically significant (34%) reduction in proteinuria from baseline compared to those given placebo (who averaged a 5% reduction) after nine months. The treatment effects for the primary endpoint of urine protein-to-creatinine ratio at 9 months were consistent across key subgroups, including key demographic and baseline disease characteristics. The most common adverse reactions in this study were hypertension, peripheral edema, muscle spasms, acne, dermatitis, weight increase, dyspnea, face edema, dyspepsia, fatigue, and hirsutism.
To learn more about IgA nephropathy and other rare kidney diseases, visit checkrare.com/diseases/kidney
Reference
Calliditas Therapeutics AB [press release]. FDA grants Calliditas Therapeutics Accelerated Approval of TARPEYO™ (budesonide) to Reduce Proteinuria in IgA Nephropathy. Dec 15, 2021. https://www.prnewswire.com/news-releases/fda-grants-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy-301445918.html