WASHINGTON, Jan. 22, 2021 /PRNewswire/ -- 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. Today, Aurinia Pharmaceuticals announced they received authorization from the FDA to market Lupkynis™ (voclosporin), a first-ever oral therapy for lupus nephritis that blocks a protein in the immune system called calcineurin. The company 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.
Lupus is an unpredictable and misunderstood autoimmune disease that ravages different parts of the body. It is difficult to diagnose, hard to live with, and a challenge to treat. Lupus is a cruel mystery because it is hidden from view and undefined, has a range of symptoms, strikes without warning, and has no known cause and no known cure. Its health effects can range from a skin rash to a heart attack. Lupus is debilitating and destructive and can be fatal, yet research on lupus remains underfunded relative to diseases of similar scope and devastation.
About the Lupus Foundation of America
The Lupus Foundation of America is the national force devoted to solving the mystery of lupus, one of the world's cruelest, most unpredictable and devastating diseases, while giving caring support to those who suffer from its brutal impact. Through a comprehensive program of research, education, and advocacy, we lead the fight to improve the quality of life for all people affected by lupus. Learn more about the Lupus Foundation of America at lupus.org.
SOURCE Lupus Foundation of America