2022-11-28| Trials & Approvals

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

by Joy Lin
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Everest Medicines’ Nefecon, an experimental treatment for primary immunoglobulin A nephropathy (IgAN) has been put on the fast track for approval by the drug regulators of Taiwan and Korea. 

Nefecon is an oral, delayed-release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that goes through substantial first-pass metabolism. The drug targets mucosal B-cells in the ileum where IgAN originates.

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Accepted For Approval By China’s Drug Regulator

Nefecon is marketed in the US under the brand name Tarpeyo and in the EU as Kinpegyo. Earlier this month, a New Drug Application (NDA) for Nefecon was accepted by China’s National Medical Products Administration (NMPA) for the treatment of primary IgAN for adults at risk of rapid disease progression. 

“Chronic kidney disease is one of the most serious public health problems in China, where IgAN affects around five million people,” said Rogers Yongqing Luo, CEO of Everest. 

“Nefecon’s NDA acceptance marks a significant milestone in bringing this first-in-disease treatment to IgAN patients in China. Nefecon, which leads our renal disease portfolio, will be the next focus of commercialization for Everest, and we look forward to working closely with the regulatory authority to bring this innovative treatment to patients in China as quickly as possible.”

Improving Protein Excretion And Kidney Function

The Accelerated Approval Designation (AAD) bestowed by the Taiwan FDA to Nefecon is based on topline results from a pivotal global Phase 3 clinical trial called NeflgArd. Meanwhile, the Orphan Drug Designation (ODD) given by Korea’s Ministry of Food and Drug Safety to Nefecon will speed up NDA filing and approval. 

In NeflgArd, the urine protein-to-creatinine ratio (UPCR) of patients treated with Nefecon was shown to be 27% lower than the placebo at nine months. Additionally, Nefecon treatment resulted in an eGFR (glomerular filtration rate) improvement of 3.87 ml/min/1.73m2. The drug was found to be well-tolerated.

According to a 2019 licensing deal with Calliditas Therapeutics,  Everest is developing and marketing Nefecon in Mainland China, Hong Kong, Macau, Taiwan, and Singapore. The company this March added South Korea to its list of territories. 

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