CareMed Has Been Selected as a National Specialty Pharmacy Partner for VANRAFIA™ (atrasentan)
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 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™.
About CareMed Specialty Pharmacy:
CareMed is an independent Specialty Pharmacy that is an affiliate of Onco360 Specialty Pharmacy. CareMed was founded to bring together the stakeholders involved in rare and complex disease treatment process and serve the specialized needs of patients, providers, hospitals, manufacturers, health plans, and payers. CareMed is headquartered in New Hyde Park, New York, and is a specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. It is accredited through URAC, ACHC, and NAPB as a Digital Pharmacy. For more information about CareMed, please visit CareMedSP.com.
Media Contact: Benito Fernandez, Chief Commercial Officer
Benito.Fernandez@Onco360.com | 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
