Positive Phase III trial supports Kinpeygo as IgAN therapy

Positive safety and efficacy data from a pivotal Phase III clinical trial have just been published in leading nephrology journal Kidney International, and lend further support to the recent European launch of Kinpeygo (budesonide; development name: Nefecon). The targeted-release capsules are the only medicine authorized in the European Union for treating immunoglobulin A nephropathy (IgAN).

The drug’s developer is Sweden’s Calliditas Therapeutics (STO: CALTX). Kinpeygo, which gained European Commission approval in July this year, is licensed for marketing in the European Economic Area (EEA) exclusively by Germany’s STADA Arzneimittel (SAZ: Xetra). It was introduced onto the US market in January this year, and analysts have forecast sales in excess of $1 billion.

Results from NefIgArd Part A, pivotal Phase III, randomized, double-blind, placebo-controlled, multicenter study highlight safety and efficacy data related to both proteinuria and estimated glomerular filtration rate (eGFR) for 199 adult patients treated with Kinpeygo or placebo while on background of optimized and stable renin-angiotensin system inhibitor (RASi) therapy.