March 10, 2011
2 min read

First new lupus drug approved by FDA in more than 50 years

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The FDA has approved belimumab to treat patients with active, autoantibody-positive lupus —systemic lupus erythematosus — who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives and NSAIDs, according to an FDA press release.

Human Genome Sciences Inc. (HGSI), based in Rockville, Md., developed belimumab (Benlysta) and will co-market the drug in the United States with GlaxoSmithKline (GSK), of Philadelphia. In a joint press release, the companies noted that Benlysta could be available to physicians and patients before the end of March.

The recommended belimumab dosage regimen in the U.S. is 10 mg/kg intravenous infusion at 2-week intervals for the first three doses and at 4-week intervals thereafter, according to prescribing information at HGSI’s website.

“We and GSK are honored to have the opportunity, with the approval of FDA, to bring Benlysta forward in the United States as the first new drug for systemic lupus in more than 50 years,” HGSI President and Chief Executive Officer H. Thomas Watkins stated in the companies’ release. “We expect to have this novel therapy available to physicians and patients within about 2 weeks, and our entire organization looks forward to the positive impact we hope this new therapy will have for patients with systemic lupus.”


FDA last approved hydroxychloroquine (Plaquenil) and corticosteroids in 1955 to treat lupus. Aspirin was approved to treat lupus in 1948, according to the FDA release.

“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,” Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, stated in the FDA release.

The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or intravenous cyclophosphamide. The U.S. labeling includes those limitations of use. “Use of belimumab is, therefore, not recommended in these situations,” according to HGSI/GSK joint press release.

Additional study

African American patients and patients of African heritage in the two clinical studies on which approval was based, did not appear to respond to treatment with the drug, and the studies lacked sufficient numbers to establish a definite conclusion. To address this concern, the FDA noted in its release that the sponsor has agreed to conduct an additional study to further evaluate the safety and effectiveness of the drug for this subgroup of patients.

There were more deaths and serious infections reported in patients who received Benlysta during the clinical studies than those receiving 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, according to the FDA release.

As reported on the, the FDA Arthritis Advisory Committee voted 13-2 in favor of approving a biologic license for belimumab in November.



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