Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) for Nefecon (sustained-release budesonide) has been accepted for review by South Korea’s Ministry of Food and Drug Safety (MFDS). The therapy is under consideration for approval as a treatment for primary immunoglobulin A nephropathy (IgAN) in adult patients, with a regulatory decision anticipated in 2024.
Earlier this year, South Korea’s MFDS granted Nefecon the Global Innovative product on Fast Track (GIFT) designation, making it the second product and the first non-oncology product to be included in the MFDS’ GIFT program. Inclusion in the GIFT program is expected to expedite the regulatory review process by 25% and allows for a rolling review.
Nefecon is a patented oral, delayed-release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first-pass metabolism. The formulation is designed as a delayed-release capsule that is enteric coated and remains intact until it reaches the Peyer’s patch region of the lower small intestine. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, securing exclusive rights to develop and commercialize Nefecon in mainland China, Hong Kong, Macau, Taiwan, and Singapore. This agreement was extended in March 2022 to include South Korea within Everest Medicines’ territories. The drug received marketing approval in Macau and mainland China in October and November of this year, respectively.- Flcube.com
