Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received market approval from the Taiwan Food and Drug Administration for its targeted-release budesonide, Nefecon, for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. This approval allows for the use of Nefecon to delay renal function decline without limitations on baseline proteinuria levels.
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, granting Everest Medicines the rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan, and Singapore. This agreement was expanded in March 2022 to include South Korea.
Nefecon has received marketing approval in Macau, mainland China, Singapore, and Hong Kong in October 2023, November 2023, March 2024, and May 2024, respectively. The approval is supported by the results of the Phase III NefIgArd study, which demonstrated that Nefecon, compared to placebo, consistently reduced proteinuria, decreased the risk of microscopic hematuria, and reduced the decline in renal function by up to 50%. It is expected to delay the progression of the disease to dialysis or kidney transplantation by 12.8 years. Nefecon is also under regulatory review in South Korea.
This series of approvals underscores Everest Medicines’ commitment to expanding access to Nefecon for patients with IgAN across the Asia-Pacific region and highlights the drug’s potential to significantly improve patient outcomes.- Flcube.com
