For Immediate Release: March 9, 2011
Media Inquiries: Erica
Jefferson, 301-796-4988, firstname.lastname@example.org; Morgan Liscinsky, 301-796-0397,
Consumer Inquiries: 888-INFO-FDA
approves Benlysta to treat lupus
First new lupus drug approved in 56 years
The U.S. Food and Drug Administration today approved Benlysta (belimumab) to treat
patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving
standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal
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
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.
Estimates vary on the number of lupus sufferers in the United States ranging from approximately
300,000 to 1.5 million people. 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.
“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.
studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta.
The studies diagnosed patients with active lupus and randomized them 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
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.
Sciences Inc., based in Rockville, Md., developed Benlysta and will co-market the drug in the United
States with GlaxoSmithKline of Philadelphia.