Fierce Pharma2d
Vanrafia, 2nd drug in Novartis' IgAN troika, crosses FDA finish line in payday for Chinook investors
When Novartis bought kidney disease biotech Chinook Therapeutics in 2023 for $3.2 billion upfront, the deal included a ...
MPR1d
Vanrafia Gets Accelerated Approval for Immunoglobulin A Nephropathy
The Food and Drug Administration (FDA) has granted accelerated approval to Vanrafia ® (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid ...
Pharmaceutical Technology on MSN2d
FDA grants accelerated approval to Novartis’ Vanrafia for IgAN
The approval is supported by a prespecified interim analysis from the ongoing, randomised Phase III ALIGN trial.
PharmExec1d
FDA Approves Novartis’ Vanrafia for Primary Immunoglobulin A Nephropathy
Approval was based on results from the Phase III ALIGN study, which demonstrated a significant reduction in proteinuria at 36 ...
Medical Dialogues23h
FDA Grants Accelerated Approval to Atrasentan for IgA Nephropathy
The US FDA has granted accelerated approval to atrasentan (Vanrafia) for reducing proteinuria in adults with primary ...
PMLive1d
Novartis’ Vanrafia granted FDA approval for rare kidney disease IgA nephropathy
Novartis’ Vanrafia (atrasentan) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat ...
Managed Healthcare Executive2d
FDA Grants Accelerated Approval to Vanrafia for IgAN, a Rare Kidney Disease
Vanrafia reduces proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). It has a wholesale acquisition cost ...
pharmaphorum2d
Novartis gets FDA nod for second of three IgAN drugs
Vanrafia (atrasentan) is the first drug in the selective endothelin A receptor antagonist (ERA) class to be cleared in the US ...
Zacks Investment Research on MSN1d
Pharma Stock Roundup: FDA Nod to SNY, AZN & NVS, JNJ Talc Suits Failure
This week, the FDA approved Sanofi’s SNY hemophilia therapy, fitusiran, Novartis’ NVS Vanrafia for the reduction of ...
Novartis Secures Third FDA Approval For Its Kidney Disease Portfolio In One Year
FDA grants accelerated approval to Novartis' Vanrafia for IgA nephropathy, with Phase 3 data in 2026 expected to support ...
Seeking Alpha3d
Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA ...
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 ...
Renal & Urology News3d
Vanrafia Gets Accelerated Approval for Immunoglobulin A Nephropathy
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 ...