Nefecon (targeted-release formulation-budesonide) for the treatment of IgA nephropathy

Abstract

Budesonide is a second-generation synthetic, nonhalogenated corticosteroid; it acts locally with minimal systemic absorption. The oral formulation Nefecon® is under clinical development from the treatment of IgA nephropathy. Thanks to its specific formulation, it could inhibit the pathogenetic process of IgA nephropathy at its source while avoiding the toxicity of systemic glucocorticoids. A Phase II clinical trial has shown a statistically significant antiproteinuric effect of budesonide on top of therapy with inhibitors of the renin-angiotensin system, with a good safety profile. More recently, preliminary results of a larger, Phase III clinical trial have confirmed the antiproteinuric efficacy of oral budesonide. These findings were submitted to the US FDA and the EMA to undergo fast revision and approval for clinical use.