Everest Medicines has announced a significant milestone in the battle against primary immunoglobulin A nephropathy (IgAN) with the approval of NEFEGAN® by the Singapore Health Sciences Authority (HSA). 

NEFEGAN®, also known as Nefecon® in other Everest territories, stands as the first-ever treatment for IgAN to receive full approval from the US Food and Drug Administration. Following its successful approval in Macao and mainland China, Singapore becomes the third region in Everest territories to grant New Drug Application (NDA) approval for NEFEGAN®.

In light of this achievement, Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, emphasized the significance of this approval for IgAN patients in the region, stating, "The NDA approval in Singapore marks an important event for IgAN patients in the region as we continue to expand patient access to Nefecon® throughout Asia, an area of high IgAN disease prevalence."

The approval in Singapore comes on the heels of the Phase 3 NefIgArd clinical trial, a rigorous study evaluating the efficacy and safety of Nefecon® in adult patients with primary IgAN on optimized RASi therapy. The trial, a randomized, double-blind, multicenter endeavor, demonstrated compelling results, with the primary endpoint showing a statistically significant and clinically meaningful benefit of Nefecon® over placebo (p-value < 0.0001).

Moreover, the trial revealed a notable difference in 2-year total estimated glomerular filtration rate (eGFR) slope in favor of Nefecon®, highlighting its potential to slow disease progression. Importantly, these benefits were observed across the entire study population, irrespective of baseline levels of urinary protein-to-creatinine ratio (UPCR).

Further analysis of the trial data, encompassing a diverse patient population, showcased promising outcomes across different ethnicities. The full two-year results of the NefIgArd trial underscored the efficacy of Nefecon® in preserving kidney function, with both Asian and White patient subgroups experiencing a reduction in proteinuria and stabilization of eGFR when compared to placebo.

As Everest Medicines works towards expanding the availability of Nefecon® to more underserved patients in 2024, including those in Hong Kong, Taiwan, and South Korea, the approval in Singapore marks a significant stride in the global fight against IgAN. With its innovative approach targeting the origin of the disease, Nefecon® offers hope for improved outcomes and enhanced quality of life for patients battling IgAN.