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  • 'Vanrafia' for rare kidney disease receives ODD in Korea
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Aug 12, 2025 06:16am
The FDA granted accelerated approval for Vanrafia's indication to treat primary immunoglobulin A nephropathy (IgAN)
Phase 3 ALIGN study confirmed proteinuria reduction
A new drug for rare kidney disease, 'Vanrafia,' has been granted orphan drug designation in Korea.

The Ministry of Food and Drug Safety (MFDS) recently announced this through notificiation board. The indication for the designation is to 'treat adult patients with primary immunoglobulin A nephropathy (IgAN) with a urine protein-to-creatinine ratio (UPCR) over 1.5g/g.'

Vanrafia (atrasentan) received accelerated approval from the FDA in April.

This drug is a once-daily oral non-steroidal therapeutic agent that can be used in combination with supportive therapy, including a renin-angiotensin system inhibitor. It can also be used in combination with an SGLT-2 inhibitor.

The efficacy of Vanrafia was proven th
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