CareMed, an independent specialty pharmacy, is in the Limited Distribution Network for Vanrafia^™ (atrasentan), for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) and are at risk of rapid disease progression. This is generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.¹ Vanrafia™ is a once-daily, non-steroidal, oral therapy that can be added onto supportive care, including a renin-angiotensin system (RAS) inhibitor with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor. Vanrafia™ was granted accelerated approval based on a prespecified interim analysis of the Phase III ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo.  

“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 nephropathy (IgAN) to our portfolio of Limited Distribution therapies.”

The FDA’s accelerated approval of Vanrafia™ is based on the results of the ongoing Phase III ALIGN study, where patients receiving Vanrafia™ in combination with a RAS inhibitor achieved clinically meaningful and statistically significant proteinuria reduction of 38.1% compared to placebo, with results seen as early as week six and sustained through week 36. ALIGN study is a Phase III clinical trial comparing the efficacy and safety of Vanrafia™ versus placebo in patients with IgAN at risk of progressive loss of kidney function. The ALIGN study evaluated 340 patients with biopsy-proven IgAN and a baseline of total proteinuria ≥1 g/day despite optimized RAS inhibitor treatment. They were randomized to receive once-daily, oral Vanrafia (0.75 mg) or placebo for approximately 132 weeks. The primary efficacy endpoint for the interim analysis is change in proteinuria, as measured by 24-hour UPCR from baseline to 36 weeks.

The safety data for the ALIGN trial showed that Vanrafia™ is well tolerated with adverse events reported in ≥2% of patients treated with Vanrafia™, and were found more frequently with the placebo, including peripheral edema, anemia, and liver transaminase elevation. Clinicians should obtain liver enzyme testing before initiating Vanrafia™ and during treatment when clinically indicated, because some endothelin receptor antagonists have caused elevations of aminotransferases, hepatotoxicity, and liver failure.