Everest Medicines announced today that NEFECON has received full approval from China's National Medical Products Administration (NMPA) through a supplemental New Drug Application (sNDA). This regulatory decision significantly expands the eligible patient population by removing previous restrictions that required elevated proteinuria levels, now allowing treatment for all adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.
The approval establishes NEFECON as the first and only etiological treatment for IgAN to receive full approval in China, positioning it as a foundational first-line therapy for this serious kidney condition.
Expanded Treatment Access for IgAN Patients
"The full approval of NEFECON in China marks a significant milestone, providing a foundational first-line treatment for IgAN patients, regardless of proteinuria levels, and addressing critical unmet clinical needs," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.
With over 100,000 new IgAN cases diagnosed annually in China, the disease represents a substantial burden on the healthcare system. The inclusion of NEFECON in the National Reimbursement Drug List (NRDL), now available in 31 provinces and cities across China, significantly improves both accessibility and affordability for patients.
Robust Clinical Evidence Supporting Approval
The NMPA's decision is backed by comprehensive data from the global Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study that evaluated NEFECON (16 mg once daily) against placebo in patients receiving optimized RASi therapy.
In the global study population, NEFECON demonstrated statistically significant and clinically meaningful benefits in preserving estimated glomerular filtration rate (eGFR) over a two-year period, which included 9 months of active treatment followed by 15 months of follow-up without the drug. The treatment also produced durable reductions in urine protein creatinine ratio (UPCR) and decreased microhematuria.
Results from the China subpopulation were particularly impressive, showing NEFECON reduced the rate of kidney function decline by 66% and delayed the need for dialysis or kidney transplantation by an estimated 12.8 years. These outcomes highlight the drug's potential to transform long-term disease management for Chinese patients with IgAN.
Global Regulatory Success and Commercial Expansion
NEFECON has achieved regulatory approval across all of Everest Medicines' territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan, Singapore, and South Korea. The drug is already commercially available in mainland China, Hong Kong, Macau, and Singapore, with launches planned for Taiwan and South Korea later this year.
This broad regulatory success follows earlier approvals by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), confirming the global recognition of NEFECON's clinical value.
Addressing the Unmet Need in IgA Nephropathy
IgA nephropathy is characterized by the buildup of immunoglobulin A in the kidneys, leading to inflammation and progressive kidney damage. Prior to NEFECON, treatment options were limited primarily to supportive care and management of symptoms rather than addressing the underlying disease process.
As an etiological treatment, NEFECON targets the disease mechanism itself, offering a more comprehensive approach to management. The removal of proteinuria requirements in the approval criteria allows for earlier intervention in the disease course, potentially preventing irreversible kidney damage in more patients.
Future Implications for Renal Disease Management
The full approval of NEFECON represents a significant advancement in Everest Medicines' leadership in the renal disease sector. By providing an effective treatment option that addresses the root cause of IgAN, NEFECON may reduce the long-term burden of end-stage renal disease and the need for dialysis or transplantation.
This milestone demonstrates Everest's commitment to bringing innovative treatments to patients with serious kidney conditions and provides a foundation for future developments in nephrology care throughout Asia.
