MFDS Approves 'Vanrafia' for IgA Nephropathy in South Korea

Expedited review as GIFT No. 53

A new treatment for IgA nephropathy, a rare kidney disease that can progressively impair kidney function and eventually require dialysis, is coming to South Korea.

Ministry of Food and Drug Safety in Cheongju, North Chungcheong Province. The Asia Business Daily DB

On November 3, the Ministry of Food and Drug Safety (MFDS) announced that it had approved Vanrafia 0.75 mg film-coated tablets (active ingredient: atrasentan hydrochloride), a treatment for primary IgA nephropathy in adults. The imported orphan drug is intended for patients with a urinary protein-to-creatinine ratio (UPCR) of 1.5 g/g or higher.

IgA nephropathy is a disease in which immunoglobulin A accumulates in the glomeruli of the kidneys, causing inflammation and reducing kidney function. Primary IgA nephropathy can progressively impair kidney function over time and develop into end-stage kidney disease.

Vanrafia selectively blocks the action of endothelin A receptors, which are involved in kidney damage. It reduces proteinuria and slows the decline in kidney function.

The MFDS designated Vanrafia as No. 53 under its Global Innovative Products on Fast Track (GIFT) program and conducted an expedited review. GIFT is a program that supports the development of innovative global medical products from the early stages so they can be brought to market quickly.

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