• 20 Nov 2024
• Admin
• News Article

Everest Medicines Announces NEFECON® Has Received Full Approval from MFDS

Everest Medicines Announces NEFECON® Has Received Full Approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for the Treatment of Primary IgA Nephropathy

Overview

Everest Medicines, a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that NEFECON® has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea, indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g). The approval of NEFECON® in South Korea further expands its reach across Asia, bringing new hope to more patients in the region suffering from IgAN.

Words from the CEO: Everest Medicines

• “As the world's first and only IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA), NEFECON® will provide a new treatment option for patients in South Korea.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.” 
• IgAN is highly prevalent among Asian populations, with a 56% higher risk of progression to end-stage renal disease compared to other groups, and often progresses more rapidly. We will continue to work on enhancing the accessibility and affordability of NEFECON® across Asia to meet the urgent needs of more IgAN patients for this innovative therapy.”

Behind the NEFECON® Approval

• The approval of NEFECON® in South Korea is based on the global Phase 3 NefIgArd clinical trial, which showed that compared to placebo, NEFECON® not only brought about a sustained reduction in proteinuria and reduced the frequency of microscopic hematuria but also demonstrated clinically relevant and statistically significant treatment benefits in estimated glomerular filtration rate (eGFR), reducing the decline in kidney function by 50% over a period of 2 years, comprising 9 months of treatment and 15 months of observation, and potentially delaying the progression to dialysis or kidney transplantation by 12.8 years.
• Additionally, the complete 2-year data of the NefIgArd study further analyzed the potential differences in the response to NEFECON® treatment between Asians (n=83) and Caucasians (n=275). 
• The results showed that compared to placebo, treatment with NEFECON® for 9 months in both Asians and Caucasians can significantly delay the decline of eGFR, protect kidney function, and bring about a sustained reduction in proteinuria and reduce the risk of microscopic hematuria.

NEFECON® in China

• NEFECON® has been prescribed in mainland China since May this year and has been approved in Macau, Hong Kong and Taiwan, and in Singapore under the trade name Nefegan®. 
• In July this year, the National Medical Products Administration in China officially accepted the supplementary application for the complete data of the final clinical trial stage of NEFECON®, and NEFECON® is expected to become the first and only fully approved etiological treatment for IgAN in China.

About NEFECON®

• 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 so that it remains intact until it releases budesonide to the distal ileum. 
• Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.

The License Agreement

• In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas Therapeutics, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON® in Mainland China, Hong Kong, Macau, Taiwan, China and Singapore. 
• The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.

About Everest Medicines

• Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. 
• The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. 
• Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. 
• For more information, please visit its website at www.everestmedicines.com.