FDA approves Lupkynis as first oral treatment for lupus nephritis

For the second time in less than two months, the U.S. Food and Drug Administration (FDA) has approved a new medication to treat adults with lupus nephritis (lupus-related kidney disease) in combination with a background immunosuppressive therapy regimen.

Aurinia Pharmaceuticals  the company that received authorization from the FDA to market Lupkynis™ (voclosporin), previously had reported positive data from a late-stage clinical study that demonstrated Lupkynis was superior to standard of care for treating lupus nephritis.

Lupkynis is an immunosuppressant drug that binds to the enzyme calcineurin, a signaling protein that activates T cells, an essential part of the body's immune system. By binding to calcineurin, Lupkynis blocks T cells from triggering an autoimmune response, reducing inflammation in the kidneys. Large clinical trials of Lupkynis showed it, plus standard of care, had a significantly higher renal response and a faster clinical response over standard of care therapy alone.

"A new treatment option to fight lupus nephritis, one of the most devastating impacts of lupus, is a significant moment to celebrate," said Stevan W. Gibson, president and CEO, Lupus Foundation of America. "For a long time, there were no approved treatments for this potentially disabling and life-threatening complication of lupus. We are thrilled that doctors now have a second new option to treat lupus nephritis, which affects up to 60% of people with lupus."

"I'm excited about having a targeted and potentially viable option in my lupus nephritis journey, shared Monique Gore-Massy, Lupus Foundation of America Ambassador. "This is an exceptional time in lupus science! People like me look forward to having their unmet treatment options addressed, and new options to manage lupus nephritis and their entire livelihood. We have renewed hope!"

"It is exhilarating to see rapid progress in new therapies becoming available for people with lupus," said Susan M. Manzi, MD, MPH, Board Chair and Medical Director for the Lupus Foundation of America and Chair, Allegheny Health Network Medicine Institute and Director, Lupus Center of Excellence. "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."

Karen H. Costenbader, MD, MPH, Director of the Lupus Program at Brigham and Women's Hospital in Boston and chair of the Lupus Foundation of America's Medical-Scientific Advisory Council, praised the people with lupus who participate in studies of potential new treatments. "Without these dedicated clinical trial volunteers, it would not be possible to secure the approval of new life-saving and life-improving treatments for lupus. And with more lupus clinical trials in various stages of planning, volunteer involvement will continue to be vital to ensure the development of more lupus therapies."

The Lupus Foundation of America supported the development of Lupkynis by educating people with lupus about the importance of participating in clinical trials for this new therapy. As part of its efforts to continue engaging people with lupus in ongoing research, the Foundation recently launched an online data platform, RAY™ (Research Accelerated by You). This platform enables people with lupus and caregivers to share their lupus experiences that can help researchers accelerate new treatments and improve disease outcomes.

People with lupus and their family members can also help the Lupus Foundation of America advance funding for lupus research through advocacy efforts. Registration is now open for the 2021 Digital Lupus Advocacy Summit scheduled for March 2-4. The three-day summit agenda includes online programs and workshops, and virtual meetings with members of the United States Congress.