布地奈德缓释胶囊获美国FDA批准用于减少IgA肾病蛋白尿！

Budesonide extended-release capsules are first-line anti-inflammatory drugs and locally acting glucocorticoids currently used to treat Crohn's disease (capsules) and ulcerative colitis (enema). On December 16, 2021, the US FDA has accelerated its approval for marketing to reduce the risk of rapid progression of primary immunoglobulin A nephropathy (IgA nephropathy) in adult patients. It is the first and only drug in the world approved by the FDA to specifically treat this indication.

Efficacy data of budesonide sustained-release capsules in reducing proteinuria in IgA nephropathy!

This phase III, placebo-controlled, multi-center study aims to evaluate the efficacy and safety of Tarpeyo 16 mg once-daily dosing of budesonide extended-release capsules based on optimized RASi therapy compared with placebo in adult patients with primary IgA nephropathy (N=360).

The results showed that the study met the primary endpoint of Part A, which was to demonstrate that compared with placebo, Tarpeyo 16 mg once daily administration of budesonide extended-release capsules showed a statistically significant reduction in urinary protein to creatinine ratio, i.e. UPCR, or proteinuria after 9 months of treatment. At nine months, patients who received Tarpeyo plus RASi (n=97) had a statistically significant 34% reduction from baseline, compared with a 5% reduction in patients who received RASi alone (n=102), resulting in a 31% reduction in UPCR.

Primary immunoglobulin A nephropathy (IgAN) is a rare, progressive, chronic autoimmune disease. Budesonide sustained-release capsules inhibit immune responses and reduce antibody synthesis, and can enhance the stability of endothelial cells, smooth muscle cells and lysosomal membranes. Budesonide extended-release capsules are significantly lipophilic, have very high affinity for receptors, and can be rapidly absorbed in the intestine. It should be noted that people who are allergic to any component of budesonide are prohibited from using this drug.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.

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