Breakthrough: Everest Medicines's Nefecon® Receives HSA Approval for New Drug Launch

In a significant development, Everest Medicines announced that Nefecon®, their groundbreaking drug for the treatment of primary IgA nephropathy in adults at risk of disease progression, has received approval from the Health Sciences Authority (HSA) in Singapore. This marks the third region, following Mainland China and Macau, to grant market approval for Nefecon®. The approval not only expands patient accessibility in Asia but also establishes Nefecon® as the first and only IgA nephropathy-specific therapeutic agent approved by the U.S. Food and Drug Administration.

March 20th, 2024 - Everest Medicines's cutting-edge drug, Nefecon®, has been granted approval by the Health Sciences Authority (HSA) in Singapore for the treatment of primary IgA nephropathy in adults with an increased risk of disease progression. This approval comes after its successful authorization in Mainland China and Macau, solidifying Nefecon® as a breakthrough treatment option for patients in Asia.

Nefecon® has demonstrated exceptional efficacy and safety data in the Phase III clinical trial, NefIgArd. This randomized, double-blind, multicenter study evaluated the effectiveness and safety of Nefecon® (16 mg/day, once-daily) compared to a placebo in adult patients with primary IgA nephropathy who were receiving optimized renin-angiotensin system (RAS) inhibitor therapy. The study spanned two years, including a nine-month treatment period with Nefecon® or placebo, followed by a 15-month follow-up period after discontinuation. The global study results revealed that Nefecon® not only led to sustained reduction in proteinuria and decreased risk of microscopic hematuria compared to the placebo but also demonstrated clinically relevant and statistically significant therapeutic benefits in estimated glomerular filtration rate (eGFR) (p<0.0001). It was able to reduce the decline in renal function by 50%, thereby delaying disease progression to dialysis or kidney transplantation by an estimated 12.8 years.

Further analysis of the complete two-year data from the NefIgArd study explored potential differences in treatment response to Nefecon® between Asian (n=83) and Caucasian (n=275) populations. The results indicated that Nefecon® treatment, compared to the placebo, significantly and sustainably delayed eGFR decline, preserved kidney function, and reduced the risk of proteinuria and microscopic hematuria, irrespective of whether the patients were Asian or Caucasian.

Nefecon® (Nefecon®) is an orally administered delayed-release budesonide capsule and the only targeted treatment for IgA nephropathy worldwide. It acts as a mucosal immunomodulator that targets the intestinal mucosa, reducing renal function decline by 50% and delaying disease progression to dialysis or kidney transplantation by an estimated 12.8 years in the Chinese population. Budesonide is a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity, with a first-pass metabolism of 90% and excellent safety profile.

Everest Medicines entered into an exclusive licensing agreement with Calliditas in June 2019, granting them the rights for the development and commercialization of Nefecon® in Greater China and Singapore. The agreement was expanded in March 2022 to include South Korea within Everest Medicines's authorized licensing scope.

The approval of Nefecon® by the Health Sciences Authority (HSA) in Singapore is a significant milestone for Everest Medicines and a breakthrough for patients with primary IgA nephropathy in Asia. With its remarkable efficacy and safety profile demonstrated in the NefIgArd study, Nefecon® offers new hope for patients by delaying disease progression and preserving kidney function. As Everest Medicines continues its mission to provide innovative treatments, Nefecon® paves the way for improved patient outcomes and a brighter future for individuals affected by IgA nephropathy.