By David Colburn
Staff Writer
Although lupus is not an incredibly common disease, it is often one of notable severity. AOL Health states that the autoimmune disease results in inflammation, swelling and tissue damage throughout the body. News of a newly approved medicinal treatment may provide a sense of solace to those affected by lupus.
According to ORTHOSuperSite.com, the FDA’s decision to approve belimumab (Benlysta) to treat patients with systematic lupus erythematosus marks the first new treatment option since 1955. A biologic license was approved in a 13-2 decision by the FDA Arthritis Advisory Committee in November 2010. Prior to early March of 2011, FDA previously approved hydroxychloroquine (Plaquenil) and corticosteroids in 1955 and aspirin in 1948. The treatment is meant to be used in conjunction with standard therapies such as antimalarial and immunosuppressive according to the FDA.
ORTHOSuperSite.com confirms that Human Genome Science, Inc. (HGSI) developed belimumab, which will be co-marketed with Philadelphia-based GlaxoSmithKline (GSK) in the United States. President and CEO of HGSI, H. Thomas Watkins, commented on the decision in a press release: “We and GSK are honored to have this opportunity, with the approval of FDA, to bring Benlysta forward in the United States as the first new drugs for systemic lupus in more than 50 years…Our entire organization looks forward to the positive impact we hope this new therapy will have for systemic lupus.”
HGSI has recommended a dosage regimen of 10 milligrams per kilogram (mg/kg) administered into the patient’s veins at two-week intervals for the first three doses and subsequent intervals of four weeks. The Hospital for Special Surgery states that HGSI and GSK conducted a 52-week, double-blind, placebo-controlled trial known as BLISS-52. Belimumab or a placebo was applied in 10mg/kg or 1 mg/kg doses to 865 randomized patients in addition to standard lupus medications. The study was ultimately successful in meeting its predetermined primary outcome, according to the Hospital for Special Surgery’s website. A second trial known as BLISS-76 was also determined to be successful.
Despite the general optimism surrounding the FDA’s decision, belimumab does carry certain limitations. Its effectiveness has not been evaluated in those with severe active lupus nephritis or severe active central nervous system lupus, as indicated by ORTHOSuperSite.com. More deaths and infections were also reported in patients given Benlysta as opposed to placebo in clinical studies. An additional study on patients of African heritage is scheduled to be conducted in order derive more conclusive results, according to the FDA. A mandatory Medication Guide will be provided to address risks and the U.S. labeling of belimumab will confirm the drug’s limitations.
HGSI and GSK have mentioned that Benlysta could be available before the end of March 2011.
Additional information on the product can be found at: http://www.orthosupersite.com/view.aspx?rid=81422 ; & http://www.hss.edu/conditions_benlysta-belimumab-new-lupus-medication-on-horizon.asp
