Shares of Aurinia Pharmaceuticals traded 30% higher after the company reported that the U.S. Food and Drug Administration approved its LUPKYNIS™ (voclosporin) for use in treating adults with active lupus nephritis.
Integrated biopharmaceutical company Aurinia Pharmaceuticals Inc. (AUPH:NASDAQ; AUP:TSX), which is focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, announced that "the U.S. Food and Drug Administration (FDA) has approved LUPKYNIS™ (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN)."
Aurinia Pharmaceuticals advised that LUPKYNIS is now available to patients in the U.S. and the medicine now holds the distinction of being the first FDA-approved oral therapy for LN. The company noted that LN is a common and one of the most serious complications of systemic lupus erythematosus (SLE). The firm indicated that "LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events and death."
The firm stated that "in pivotal trials, patients treated with LUPKYNIS in combination with standard-of-care (SoC) were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients on typical SoC alone." The company added that "patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied."
Aurinia Pharmaceuticals' President and CEO Peter Greenleaf remarked, "The LUPKYNIS approval marks a turning point for the lupus nephritis community including patients, caregivers, families and healthcare professionals...The approved label supports the efficacy and safety of LUPKYNIS as well as Aurinia's proprietary and patented eGFR pharmacodynamic dosing protocol. We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of LUPKYNIS."
Brad H. Rovin, M.D., professor of medicine and the director of the Division of Nephrology at Ohio State University Wexler Medical Center and AURORA clinical trial investigator, commented, "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...The FDA approval of LUPKYNIS allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate."
Lupus Foundation of America President and CEO Stevan W. Gibson stated, "People with lupus nephritis have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for kidney transplant...The approval of a tailored therapy represents a significant step forward in treating lupus nephritis and is excellent news for the lupus community."
Kathleen A. Arntsen, president and CEO of Lupus and Allied Diseases Association, added, "As a patient-led organization who understands all too well the urgent need for more efficacious treatments for people struggling to live with diseases of unmet need like lupus nephritis, we are thrilled with the approval of LUPKYNIS...There is now a new treatment for this debilitating and life-diminishing condition that is four times higher for people of African descent and Asians and two times higher for Hispanics/Latinos and Native Americans."
The company stated that LUPKYNIS had been approved previously by the FDA under Priority Review and was granted Fast Track designation in 2016.
The company pointed out that the FDA's approval of LUPKYNIS was based upon data from its Phase 3 AURORA trial and Phase 2 AURA-LV 2 studies of 533 patients with LN. The firm stated that in these trials LUPKYNIS (voclosporin) showed over a period of up to 52 weeks that LUPKYNIS treatment had demonstrated significantly improved outcomes across several parameters when used in combination with the typical standard of care (SoC) treatment of mycophenolate mofetil and low dose steroids. The company noted that "in the Phase 3 study, at one year, LUPKYNIS plus SoC was more than two times as effective at achieving a complete renal response than the SoC alone."
The firm explained that LN is an inflammation of the kidney caused by serious progression of SLE, which is a complex and chronic autoimmune disease. The company indicated that around 200,000-300,000 people have SLE in the U.S. and that about one-third of them already have developed LN at the time SLE is diagnosed.
Aurinia Pharmaceuticals, based in Victoria, British Columbia, is a fully integrated biopharmaceutical company focused on developing and commercializing therapies to treat patients in the fields of nephrology and autoimmunity. The firm' LUPKYNIS (voclosporin) is now been designated as "the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN)."
Aurinia Pharmaceuticals Inc. began the day with a market cap of around $1.9 billion with approximately 126.0 million shares outstanding and a short interest of about 4.1%. AUPH shares opened 38% higher today at $20.50 (+$5.64, +37.95%) over Friday's $14.86 closing price representing a new 52-week high price for the firm's shares. The stock has traded today between $17.82 to $20.50 per share and is currently trading at $19.397 (+$4.53, +30.60%).