FDA approves Lupkynis, first-ever oral therapy for lupus nephritis
The FDA has approved voclosporin as the first oral treatment for lupus nephritis in adult patients who are receiving background immunosuppressive therapy, according to a press release from Aurinia Pharmaceuticals.
This approval makes voclosporin (Lupkynis) — a calcineurin inhibitor — the second therapy authorized to treat lupus nephritis, following GlaxoSmithKline’s Benlysta (belimumab) approval for this indication in December.
“We could not be more excited about this approval,” Kenneth M. Farber, president and chief executive officer of the Lupus Research Alliance, told Healio Rheumatology. “One month ago, there were no treatments approved specifically for lupus nephritis, and with this announcement, there are now two. Because of the heterogeneity of lupus and how it manifests, many treatment options are needed, and it is our hope that having these treatment options will personalize patient care. On behalf of the lupus community, we thank Aurinia Pharmaceuticals and GSK for developing the first two therapies that answer this critical need.”
The FDA based its approval on results from the phase 3 AURORA trial and phase 2 AURA-LV trial. A total of 553 adults with biopsy-confirmed lupus nephritis were randomized 1-to-1 to receive either 23.7 mg Lupkynis or placebo twice daily alongside standard therapy. In addition, all patients received concurrent mycophenolate mofetil at a target dose 2 g/day.
According to the study results, at 1 year, Lupkynis plus standard of care was more than twice as effective at achieving a complete renal response compared with standard of care alone. Patients who received Lupkynis also achieved a 50% reduction in their urine protein creatinine ratio twice as fast as patients receiving standard of care. Further, a higher proportion of patients treated with Lupkynis achieved a complete renal response at 24 weeks compared with patients treated with standard of care.
“It is exhilarating to see rapid progress in new therapies becoming available for people with lupus,” Susan M. Manzi, MD, MPH, medical director of the Lupus Foundation of America, and director of the Lupus Center of Excellence at Allegheny Health Network, said in a press release. “Lupkynis is the first oral treatment approved by the FDA to treat lupus nephritis. We now have two new therapies for treating a severe complication of lupus and several others in late-stage clinical trials. The future for people with lupus is bright.”
According to the FDA, the most common adverse events associated with Lupkynis — occurring in at least 3% of patients — included decreased glomerular filtration rate, hypertension, diarrhea, headache, anemia, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury and decreased appetite.
“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,” Kathleen A. Arntsen, president and CEO of Lupus and Allied Diseases Association, said in the release.
“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,” she added. “At a time when our nation faces extreme challenges such as addressing and overcoming social inequities and health disparities, this is welcome and promising news, especially since both lupus nephritis and COVID-19 disproportionately impact communities of color.”