Benlysta Gets FDA Approval. Benlysta (belimumab) has been approved by the U.S. Food and Drug Administration to treat patients with lupus. The drug is available to patients who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.
Benlysta 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.
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.Â
Two clinical 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.