CareMed Has Been Selected as a National Specialty Pharmacy Partner for VANRAFIA™ (atrasentan)

Apr 3, 2025

FOR IMMEDIATE RELEASE:

CareMed Has Been Selected as a National Specialty Pharmacy Partner for VANRAFIA™ (atrasentan)

New Hyde Park, NY — April 3, 2025 — 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.2

“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.

Please see the full Prescribing Information for Vanrafia™.

 

Media Contact: Benito Fernandez, Chief Commercial Officer

[email protected]  | 516-640-1332

 

References:

  1. VANRAFIA prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp; April 2025           
  2. Heerspink, H et al. Atrasentan in patients with IgA Nephropathy. NEJM. 2025-02, Vol.392 (6), p.544-554. Heerspink HJL, Jardine M, Kohan DE, et al. Atrasentan in Patients with IgA Nephropathy. N Engl J Med. 2025;392(6):544-554. doi:10.1056/NEJMoa2409415