FDA Approves First Drug to Treat Lupus
- By BSTQ Staff
TheU.S.Food andDrugAdministration (FDA) has approved Benlysta (belimumab) to treat patients with active autoantibody positive lupus(systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives and non steroidal anti-inflammatory drugs. Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target the B-lymphocyte stimulator (BLys) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.
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. Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard-of-care medicines. However, African American patients and those ofAfrican heritage participating in the studies did not appear to respond to treatment with Benlysta.
Prior to Benlysta, the FDA last approved the drugs Plaquenil (hydroxychloroquine) and corticosteroids to treat lupus in 1995. Aspirin was approved to treat lupus in 1948.