South Korea Puts Everest Medicines’ Nefecon On Fast Track

South Korea’s Ministry of Food and Drug Safety (MFDS) has granted fast track status to Everest Medicines’ Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN).The drug regulator previously designated Nefecon as an orphan drug last December.  

Nefecon is the second product and the first non-oncology product (the first being Genexine’s cervical cancer vaccine) to make it into MFDS’ Global Innovative product on Fast Track (GIFT) program. A GIFT candidate enjoys a 25% accelerated regulatory review time and can be accepted for rolling review. 

Related article: Everest’s Renal Drug Gets Placed On Fast Track For Approval In Taiwan And Korea 

In China, Everest has received Priority Review status for the New Drug Application (NDA) of Nefecon from the National Medical Products Administration (NMPA). Nefecon has also been awarded Accelerated Approval Designation (AAD) by the Taiwan Food and Drug Administration. In the US, the FDA granted accelerated approval to the drug under the brand name Tarpeyo in December 2021.

“We are excited to see South Korea MFDS’ designation of GIFT for Nefecon, which will significantly accelerate the review process for this first-in-disease therapy in Asia’s third-largest pharmaceutical market,” said Rogers Yongqing Luo, CEO of Everest. 

“IgAN has much higher prevalence in East Asia than the rest of the world and we hope to bring this novel therapy to this region and address unmet patient needs as soon as possible.”

Corticosteroid with Potent Glucocorticoid Activity and Weak Mineralocorticoid Activity

IgAN, also known as Berger disease, is a disorder caused by a buildup of antibodies in the kidneys. The antibodies cause local inflammation that, over time, damage the kidneys. 

Nefecon is an 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 an enteric-coated capsule directed at the Peyer’s patch region of the lower small intestine. Each capsule holds budesonide beads that target mucosal B-cells in the ileum where the disease originates. 

In the pivotal Phase 3 NeflgArd trial, Nefecon has demonstrated statistically significant 31% mean reduction in proteinuria (protein in the urine) compared to placebo. The drug also showed a statistically significant treatment benefit of 7% in estimated glomerular filtration rate compared to placebo after 9 months of treatment. 

Nefecon was originally developed by Calliditas Therapeutics. In June 2019, Everest entered a license agreement with Calliditas, which gave Everest the rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended last March to include South Korea. 

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Joy Lin

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