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

The FDA has granted accelerated approval to Vanrafia to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression.

Novartis’ Vanrafia (atrasentan) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat ...

Approval was based on results from the Phase III ALIGN study, which demonstrated a significant reduction in proteinuria at 36 weeks in patients with primary immunoglobulin A nephropathy.

The US FDA has granted accelerated approval to atrasentan (Vanrafia) for reducing proteinuria in adults with primary immunoglobulin A (IgA) nephropathy, according to an announcement by ...

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 ...

Richard Lafayette, MD, FACP, Stanford University Medical Center, explains the significance of this second approval in a month ...

“CareMed is grateful for the opportunity to become a specialty pharmacy provider for Vanrafia ™ ,” said Benito Fernandez. “We are proud to add Vanrafia ™ for the treatment of primary immunoglobulin A ...

Uplizna gains new indication; Vanrafia approved for proteinuria in IgAN; Erzofri now available for schizophrenia; setmelanotide shows promise in hypothalamic obesity; GLP-1RAs may reduce dementia risk ...

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 ...