Everest Medicines Announces Approval of NEFECON® for IgA Nephropathy Treatment
Friday, November 29, 2024
Everest Medicines today announced NEFECON®'s inclusion in China's National Reimbursement Drug List (NRDL) effective from 1 January 2025.
NEFECON® is a patented, oral, delayed-release formulation of budesonide, a corticosteroid specifically designed to target the distal ileum, where the disease is believed to originate.
NEFECON®, the world's first approved treatment for IgA nephropathy, addresses a significant unmet medical need in China, with an estimated 5 million patients and over 100,000 new diagnoses annually. Inclusion in the NRDL is expected to improve patient access to this novel treatment.
"NEFECON®'s inclusion in the NRDL recognises its value in improving patient care for IgA nephropathy," said Everest Medicines' CEO, Rogers Yongqing Luo. The company will collaborate with government departments to ensure effective implementation of medical insurance policies for the benefit of Chinese IgAN patients.
IgA nephropathy is a prevalent kidney disease in China, particularly impacting young adults, with faster progression and poorer prognosis compared to Western populations. As the first approved etiological treatment in China, NEFECON® has already demonstrably benefited patients.
Results from the Phase 3 NefIgArd clinical trial in China showed a 66% reduction in kidney function decline and a projected delay of 12.8 years in disease progression to dialysis or transplantation. NEFECON®'s innovative mechanism of action and clinical benefits have led to its recommendation in multiple treatment guidelines, solidifying its position as a first-line therapy for IgAN.
NEFECON® has been available in mainland China since May 2024. It is also approved in Macau, Hong Kong, Taiwan, South Korea, and Singapore under the trade name Nefegan®.
Originally approved by the US FDA in December 2021 under the name TARPEYO®, NEFECON® received subsequent approvals from the European Commission and MHRA (UK) in 2022 and 2023, respectively. Calliditas Therapeutics AB markets the product in the US, while STADA Arzneimittel AG is the commercial partner in Europe.
Everest Medicines holds an exclusive license agreement with Calliditas Therapeutics for NEFECON® development and commercialisation in mainland China, Hong Kong, Macau, Taiwan, and Singapore. The agreement was extended in March 2022 to include South Korea.
Source: everestmedicines.com
