20 March 2024 | News
NEFEGAN was the first ever treatment for IgAN fully approved by the US Food and Drug Administration
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Everest Medicines, a China-based biopharmaceutical company focused on the discovery, development, manufacturing and commercialisation of innovative medicines and vaccines, has announced that the Singapore Health Sciences Authority (HSA) has approved NEFEGAN for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.
NEFEGAN, known in other Everest territories as Nefecon, was the first ever treatment for IgAN fully approved by the US Food and Drug Administration, and Singapore marks the third region in Everest territories that received New Drug Application (NDA) approval after Macao and mainland China.
Nefecon is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum.
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialise Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories. The brand name in Singapore is NEFEGAN.