Oral Lupus Nephritis Drug Lupkynis (Voclosporin) Changing The Treatment Landscape
April 17, 2025 — Lupus nephritis (LN) is a serious autoimmune disease that has long lacked efficient and safe treatment options.
However, with the approval of Lupkynis® (voclosporin), developed by Aurinia Pharmaceuticals, this landscape is changing.
As the first oral lupus nephritis drug approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Lupkynis offers patients around the world a more convenient and effective treatment option.
Lupkynis Remarkable Clinical Efficacy
The approval of Lupkynis was based on the pivotal Phase III AURORA trial, which demonstrated:
A 52-week complete renal remission (CRR) rate of 40.8% in patients receiving voclosporin in combination with standard therapy (mycophenolate mofetil + low-dose steroids), which was significantly higher than that of the placebo group at 22.5%.
The urine protein creatinine ratio (UPCR) declined twice as fast as in the control group, suggesting that Lupkynis improved renal function more rapidly.
For patients with recent-onset LN, the CRR was even as high as 51.1%, much higher than the 28.3% in the control group, highlighting its advantages in early intervention.
Global Market Layout And Generic Competition
Voclosporin’s market performance is strong. 2024 data show that Lupkynis® sales in the US have reached $159 million and are expected to peak at more than $420 million in 2030.
In February 2025, Taiwan’s Maxxis Pharmaceuticals announced that its generic application had been accepted by the FDA, and it is expected to be the first company to launch a Voclosporin generic, further reducing the cost of treatment.
Safety and Future Outlook
Despite Voclosporin’s efficacy, side effects require vigilance, including increased risk of infections, hypertension and potential carcinogenicity (e.g., skin cancers and lymphomas).
Both the EMA and the FDA require strict monitoring of patients’ renal function and blood pressure.
Despite the efficacy of Lupkynis, side effects (e.g., hypertension, decreased kidney function) require monitoring. With the development of more innovative therapies (e.g., CD20 monoclonal antibody, TYK2 inhibitors), the treatment options for lupus nephritis will be further enriched.
Conclusion
The launch of Lupkynis marks a new stage in the treatment of lupus nephritis, bringing more efficient and convenient treatment options to patients worldwide.
In the future, with the optimization of combination therapies and the advancement of generics, the prognosis of LN patients is expected to further improve.
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