Benlysta Approved by FDA for Treatment of Lupus
The U.S. Food and Drug Administration (FDA) has approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus). It is the first new lupus drug to be approved in 56 years.
Benlysta has been approved for lupus patients who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.
Previous drugs approved by the FDA for treatment of lupus are Plaquenil (hydroxychloroquine) and corticosteroids, both approved in 1955, and aspirin, approved in 1948.
Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. Estimates vary on the number of lupus sufferers in the United States ranging from approximately 300,000 to 1.5 million people.
Women are disproportionately affected. The disease usually develops between ages 15 and 44. People of all races can have the disease; however, African American women have a 3 times higher incidence (number of new cases) than Caucasian women.
Lupus 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.
Benlysta is delivered directly into a vein (intravenous infusion). It 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.
“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
Two clinical studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta. In the studies patients diagnosed with active lupus were randomized to receive Benlysta plus standard therapy, or an inactive infused solution (placebo) plus standard therapy.
The studies excluded patients who had received prior B-cell targeted therapy or intravenous cyclophosphamide, and those who had active lupus involving the kidneys or central nervous system.
Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.
African American patients and patients of African heritage participating in the two studies did not appear to respond to treatment with Benlysta. The studies lacked sufficient numbers to establish a definite conclusion. To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients.
Those receiving Benlysta during clinical studies reported more deaths and serious infections compared with placebo. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with Benlysta.
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.
Human Genome Sciences Inc., based in Rockville, Md., developed Benlysta and will co-market the drug in the United States with GlaxoSmithKline of Philadelphia.