布地奈德缓释胶囊获FDA优先审评，中国已将其纳入突破性疗法

On April 28, 2021, Calliditas announced that the New Drug Application (NDA) it developed has been accepted by the FDA for the treatment of IgA nephropathy. The FDA also granted the drug priority review status, with a PDUFA date of September 15, 2021. Budesonide extended-release capsules are expected to become the first drug approved by the FDA for the treatment of IgAN.

The glucocorticoid budesonide extended-release capsule is a prototype of a second-generation topical glucocorticoid that was developed to release the drug in the terminal ileum. It has greater potency and lower systemic bioavailability, and 5 mg of budesonide extended-release capsules are equivalent to 12 mg of prednisolone.

90% of budesonide sustained-release capsules are eliminated by the liver at the first pass. Rapid elimination brings low systemic bioavailability, thereby reducing adverse reactions (except for patients with portal shunts such as portal hypertension). Its metabolites are mainly excreted in urine, with a small amount excreted in feces. Like all glucocorticoids, budesonide extended-release capsules exert their effects by binding to glucocorticoid receptors and subsequently upregulating anti-inflammatory proteins and inhibiting pro-inflammatory proteins. Budesonide sustained-release capsules target the gastrointestinal area where PP exists at high density and inhibit the gastrointestinal immune response by binding to glucocorticoid receptors in the gastrointestinal mucosa or submucosa.

Bengt et al. conducted a randomized, double-blind, placebo-controlled phase 2b trial in 62 nephrology clinics in 10 European countries. They selected 150 patients and randomly divided them into 3 groups. They were treated with 16 mg·d-1, 8 mg·d-1 budesonide sustained-release capsules and placebo for treatment and observation. This study suggests that budesonide sustained-release capsules 16 mg·d-1, combined with RAS blockade, can reduce proteinuria in IgAN patients and reduce the risk of developing end-stage renal disease in the future. Budesonide sustained-release capsules may become the first-choice specific therapeutic drug targeting intestinal mucosal immunity upstream of the onset of IgAN.

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