Excerpted from FDA News Release, dated March 9, 2011
The US Food and Drug Administration (FDA) approved Benlysta (belimumab) for the treatment of lupus patients with active autoantibody- positive systemic lupus erythematosus (SLE). The last drugs to receive FDA approval for the treatment of lupus were Plaquenil (hydroxychloroquine)and corticosteroids, in 1955 and aspirin in 1948.
“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, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
Benlysta (belimumab), a B-lymphocyte stimulator, is delivered intravenously 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.
Benlysta’s safety and effectiveness were demonstrated in two clinical studies involving 1,684 patients with lupus. 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.
Benlysta was developed by Human Genome Sciences Inc. and will be co-marketed in the US with GlaxoSmithKline. According to Human Genome Sciences, Inc., the companies plan to have this therapy available to physicians and patients by the end of March 2011.