Everest Medicines (HKG: 1952), a China-based pharmaceutical company, announced that it has received market approval from the Hong Kong Department of Health for its drug Nefecon (targeted-release budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression.
This approval marks the fourth region within Everest’s territories where Nefecon has been granted New Drug Application (NDA) approval, following similar approvals in Singapore, Macau, and mainland China. Notably, full approval from the US Food and Drug Administration (FDA) was awarded in December 2023.
In June 2019, Everest Medicines entered into an exclusive license agreement with Calliditas, which provided Everest Medicines with the exclusive rights to develop and commercialize Nefecon in Greater China and select Southeast Asian countries. In the global Phase III NefIgArd clinical trial, Nefecon showed a highly statistically significant and clinically meaningful benefit in estimated glomerular filtration rate (eGFR) over a two-year period compared to placebo. The drug also demonstrated a durable reduction in UPCR and a decline in the proportion of patients with microhematuria. Nefecon was generally well-tolerated in the Phase III clinical trial.
Subpopulation analysis from the NefIgArd trial indicated a greater treatment effect in kidney function prevention, proteinuria reduction, and microhematuria improvement in the Chinese subpopulation compared to the global population. The mean absolute change from baseline in eGFR at 24 months showed approximately 66% less deterioration in kidney function with 9-month Nefecon treatment, compared with a 50% preservation of kidney function in the global population. Chinese patients treated with Nefecon showed a 43% greater reduction in UPCR compared with placebo at 24 months and a 31% greater reduction at 9 months. In contrast, the global population saw an approximately 30% greater reduction in UPCR at both 24 months and 9 months with Nefecon treatment compared to placebo.- Flcube.com
