Asahi Kasei Corp. announced that Nefecon (marketed in the United States as TARPEYO® (budesonide) delayed release capsules), has been included in the Kidney Disease: Improving Global Outcomes (KDIGO) 2025 Clinical Practice Guideline for the Management of IgA Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV).TARPEYO is a key product in Asahi Kasei?s pharmaceutical business, which the company has identified as a strategic growth area in its medium-term management plan. The inclusion of Nefecon in the KDIGO guidelines underscores its place in therapy and is expected to further support sustainable, long-term growth within Asahi Kasei?s healthcare portfolio.
The updated KDIGO 2025 guideline aims to standardize care and improve outcomes by providing evidence-based recommendations related to IgAN diagnosis, prognosis and treatment. It is considered the global standard for nephrology practice and plays a central role in shaping treatment decisions for patients with IgAN. The KDIGO 2025 guideline suggests treatment with a 9-month course of Nefecon for patients at risk of progressive loss of kidney function, recognizing the treatment benefit of Nefecon in reducing the loss of kidney function and reducing proteinuria as demonstrated in the NefIgArd phase 3 randomized placebo-controlled trial.
The effect of Nefecon on proteinuria and kidney function was assessed in adults with biopsy-proven IgAN who were on a stable dose of maximally tolerated RAS inhibitor therapy. Adverse events were mild or moderate and generally resolved after treatment cessation. KDIGO also notes that Nefecon is the only treatment approved for IgAN to date that has been proven to reduce the levels of pathogenic forms of IgA, which is an underlying cause of the disease.
Nefecon is an oral 4 mg targeted-release formulation of budesonide, designed to dissolve in the pH of the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-IgAg1), causing IgA nephropathy. It has not been established to what extent the efficacy of Nefecon is mediated via local effects in the ileum vs.
systemic effects. Nefecon?s approval status, labeled indication, and availability vary globally. It is approved in the United States where it is marketed as TARPEYO® (budesonide) delayed-release capsules by Calliditas Therapeutics.
It is available in the European Economic Area (EEA) where it is marketed by STADA Arzneimittel AG and in select countries in Asia, including Mainland China, Hong Kong, Macau, Taiwan, and Singapore where it is marketed by Everest Medicines. It is also in development in Japan by Viatris.
