The approval is supported by a prespecified interim analysis from the ongoing, randomised Phase III ALIGN trial.

Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program 1 Phase III data showed ...

The drug, known as atrasentan and sold as Vanrafia, blocks a specific protein in the kidneys known as endothelin A (ETA) receptor, which causes inflammation and cellular damage leading to proteinuria.

Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program 1 Phase III data showed ...

Atrasentan reduced urine protein-to-creatinine ratio by 38% compared with 3% for placebo at week 36. The Food and Drug Administration (FDA) has granted accelerated approval to Vanrafia ...

Bearing the commercial moniker Vanrafia, the selective endothelin A receptor antagonist (ERA) does not have to be used under an FDA-mandated safety-related program called REMS. A sans-REMS FDA ...

NEW HYDE PARK, N.Y., April 07, 2025 (GLOBE NEWSWIRE) -- CareMed, an independent specialty pharmacy, is in the Limited Distribution Network for Vanrafia ™ (atrasentan), for the reduction of ...

Novartis' Vanrafia reduced proteinuria by 36.1% in IgAN patients using a RAS inhibitor. Continued FDA approval depends on Phase 3 ALIGN study results in 2026. Feel unsure about the market’s next ...