China-based Everest Medicines (HKG: 1952) has announced that the New Drug Application (NDA) for Nefecon (sustained-release budesonide) has been accepted for review by the Taiwan Food and Drug Administration (TFDA). The application seeks approval for the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients.
Nefecon is a patented oral, delayed-release formulation of budesonide, a corticosteroid with significant glucocorticoid activity and minimal mineralocorticoid activity, known for its substantial first-pass metabolism. As the only global treatment for IgA nephropathy, Nefecon is a mucosal immune modulator that targets the intestine, reducing the decline in renal function by 50% and delaying renal function decline by 66% in the Chinese population. The drug is projected to delay the progression of the disease to dialysis or kidney transplantation by 12.8 years.
In June 2019, Everest Medicines secured an exclusive, royalty-bearing license agreement with Calliditas, gaining exclusive rights to develop and commercialize Nefecon in mainland China, Hong Kong, Macau, Taiwan, and Singapore. This agreement was expanded in March 2022 to include South Korea within Everest Medicines’ territories. Nefecon has received marketing approval in Macau and mainland China in October and November of this year, respectively, with regulatory decisions pending in Singapore and South Korea.- Flcube.com
