Monday, August 21, 2023
Everest Medicines announced the U.S. Food and Drug Administration's (FDA) acceptance of the supplemental New Drug Application (sNDA) for Nefecon®, a medication developed by its partner Calliditas Therapeutics AB.
Nefecon® is a proprietary oral formulation of budesonide, a corticosteroid known for its potent glucocorticoid activity and weak mineralocorticoid activity. The drug is designed with a delayed-release mechanism, wherein it is encapsulated in a way that it remains intact until it reaches the distal ileum – the lower part of the small intestine.
Once there, the enteric-coated capsule releases budesonide in a targeted manner. The formulation is aimed at specifically affecting mucosal B-cells found in the ileum, which are linked to the origin of the disease according to prevailing pathogenesis models.
Nefecon® received accelerated approval in the United States due to reduced proteinuria. Recent topline results from the Phase 3 clinical trial known as NefIgArd have revealed significant positive outcomes associated with Nefecon®. In this global, randomised, double-blind, and placebo-controlled trial, Nefecon® demonstrated a statistically significant benefit compared to the placebo in terms of estimated glomerular filtration rate (eGFR).