On January 22nd, 2021, for the first time, the Office of Food and Drug Administration (FDA) has approved oral medications for kidney disease caused by lupus, which is an autoimmune disease that causes irreversible kidney damage and increases the risk of kidney failure, heart complications and death. The drug, now known as LupkinisTM, is prescribed along with immune suppressants to treat adults with active lupus nephritis. With voclosporin being the active substance, LupkinisTM demonstrated significantly improved renal response rates compared to typical standard of care (SoC) in clinical trials. As being the first oral therapy for lupus nephritis (LN) to receive FDA approval, Aurinia Pharmaceuticals Inc. has achieved a milestone in terms of medical research and proven that the benefits of the product outweigh the known risks for the intended use.
For a lengthy period of time, doctors have found it difficult to effectively treat patients with lupus nephritis. The LupkinisTM approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals – to be more efficient and safe in terms of treatment methods.
“For years treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic options, and these have been only modestly effective but highly toxic,” said Brad H. Rovin, M.D., Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, and AURORA clinical trial investigator. “The FDA approval of LupkinisTM allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate.”
The phase 3 study enrolled 357 subjects with active LN from 142 centers in 27 countries, most were females of childbearing potential. Subjects were randomized to receive either voclosporin 23.7 mg BID (N=179) or matching placebo BID (N=178) for one year in combination with MMF and steroids. The primary endpoint was renal response at Week 52 as adjudicated by an independent Clinical Endpoint Committee (CEC).
The result of the primary endpoint was met: treatment with voclosporin resulted in a clinically meaningful and statistically significant higher renal response rate compared to placebo (40.8% vs 22.5%). The odds of responding were 2.65 times greater for subjects treated with voclosporin than placebo with an absolute risk reduction of 18.3%. Alongside with the result of the primary endpoint, the outcome of the secondary endpoints also achieved statistical significant in favor of voclosporin. These data are clinically important as it has shown that an early improvement in proteinuria can be a strong predictor of positive long-term outcomes in LN.
Since December 2017, the phase 3 clinical trial of voclosporin has been conducted in Vietnam at 6 investigational sites: Cho Ray Hospital, Bach Mai Hospital, University Medical Center, National Hospital of Dermatology and Venereology, Nguyen Tri Phuong Hospital and 115 People’s Hospital with total 15 randomized patients. SMART Research Company has proudly taken part in this research as a local CRO in Vietnam and will continue to support the upcoming researches. The Quality Policy of SMART Research is to ensure the delivery of the highest standard of services and products to our clients, therefore, we are delighted to contribute to the outcome of the research and positively impact the lupus nephritis community.
Aurinia renal response in ACTIVE LUPUS With Voclosporin – full text view. (n.d.). Retrieved February 08, 2021, from https://www.clinicaltrials.gov/ct2/show/NCT03021499
FDA approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for adult patients with ACTIVE Lupus Nephritis. (2021, January 23). Retrieved February 08, 2021, from https://www.businesswire.com/news/home/20210122005501/en/FDA-Approves-Aurinia-Pharmaceuticals%E2%80%99-LUPKYNIS%E2%84%A2-voclosporin-for-Adult-Patients-with-Active-Lupus-Nephritis
FDA approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for adult patients with ACTIVE Lupus Nephritis: Aurinia Pharmaceuticals INC. (AUPH). (2021, January 22). Retrieved February 08, 2021, from https://ir.auriniapharma.com/press-releases/detail/210/fda-approves-aurinia-pharmaceuticals-lupkynis