The Food and Drug Administration (FDA) has approved the first new drug for treatment of Lupus in over five decades. The news has triggered waves of joy from organizations fighting the debilitating illness, including the Oklahoma chapter of the Lupus Foundation of America.
The U.S. Food and Drug Administration announced approval of Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.
Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus. Prior to Benlysta, FDA last approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. Aspirin was approved to treat lupus in 1948.
Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. It disproportionately affects women, and usually develops between ages 15 and 44. The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue.
In less technical terms, the disease is described by local advocates as follows:
“Lupus is an unpredictable and potentially fatal autoimmune disease in which the immune system is out of balance, causing inflammation and tissue damage to any organ system in the body. The health effects of lupus include heart attacks, strokes, seizures, miscarriages and organ failure. An estimated 1.5 million Americans and at least five million people worldwide have a form of lupus. For more information, visit www.lupus.org.”
Estimates vary on the number of lupus sufferers in the U.S., ranging from 300,000 to 1.5 million people. People of all races can have the disease; however, African-American women have a three times higher incidence (number of new cases) than Caucasian women.
Early results found the new drug ineffective with African-Americans, although results were not definitive. Sponsors of Benlysta announced plans for further studies.
The most common side effects in the studies included nausea, diarrhea, and fever (pyrexia). Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered, the FDA announcement said.
Human Genome Sciences Inc., based in Rockville, Md., developed Benlysta and will co-market the drug in the United States with GlaxoSmithKline of Philadelphia.
The Lupus Foundation of America, Oklahoma Chapter, applauded the FDA approval.
“This is a historic day for the millions of people with lupus and their families around the world who have waited more than 50 years for a treatment breakthrough for lupus,” said Sandra C. Raymond, President and CEO of the Lupus Foundation of America (LFA). “Benlysta is the first drug ever to be specifically developed to treat lupus, and is a significant first step toward reaching our goal of developing an arsenal of safe, effective, and tolerable treatments.”
In a statement sent to The City Sentinel, Lea Jensen, LFA-OK executive director, said, “We know that people with lupus and their families will have many questions about what this historic decision means for them or their loved ones. Staff and volunteers from our Chapter, along with LFA’s health educators, are ongoing resources for people with lupus in our community, are here to answer questions, and can provide the information and resources they need to live with lupus.”
Tulsa Support Group leader Lauren Myers stated, “I am so happy the FDA decided to approve Benlysta. For those of us who have lupus it is so exciting that we have our first new drug in over 50 years. This is one more huge step in the process to eventually finding a cure.”
LFA-OK Board Chair Janna Dunagan Gau said, “We are excited about the FDA’s approval of Benlysta. This is a remarkable milestone for lupus research. Lupus survivors have waited 52 years for a drug that specifically treats lupus. We will continue to support the researchers in their efforts to identify more drug therapies for the treatment of lupus and continue to support the needs of lupus survivors in our state.”
The Oklahoma Chapter of the LFA is the only volunteer organization in the state dedicated to finding the causes of and cure for lupus and providing support, services and hope to all people affected. For more about the LFA-OK, visit www.oklupus.com, or call 405-427-8787.
The LFA-OK is a member of the LFA National Network, comprised of chapters, field offices, support groups, and community representatives. The association is the oldest and largest national nonprofit health organization dedicated to finding the causes of and a cure for lupus, and providing support, services, and hope to all people affected by lupus. The LFA and its National Network are focused on programs of research, education, and advocacy.
The LFA’s National Research Program: “Bringing Down the Barriers™,” is dedicated to addressing research issues that have for decades obstructed basic biomedical, clinical, epidemiological, behavioral, and translational lupus research. The LFA’s approach to research directs funding to areas of research where gaps exist in the understanding of lupus, and to what the group deems promising areas of study in which other public and private organizations have not focused.
According to their literature, “the LFA and its national network are committed to advancing the science and medicine of lupus by: directly funding research to close the gaps in lupus research; advocating for expanded investment in research from public and private sources; leading special initiatives and forging collaborative efforts among stakeholders to address critical issues to advancing the science and medicine of lupus.”
For more information about the LFA’s National Research Program, visit www.lupus.org/research.
Note: Senior Editor Patrick B. McGuigan contributed to this report.