FDA Committee Approves First Drug in 50 Years for Lupus


Lupus patients may soon receive access to a new drug to treat the condition.

Lupus patients may soon receive access to a new drug to treat the condition, thanks to the latest research proving its efficacy and an FDA Arthritis Advisory Committee vote 13 to 2 to recommend its use.

Benlysta is manufactured by Human Genome Science, Inc (HGS) and GlacoSmithKline PLC (GSK). The vote was to approve the treatment of autoantibody-positive patients with active systemic lupus erthematosus (SLE) (http://hcp.lv/c3eMbn).

The Arthritis Advisory Committee provides independent expert advice on issues related to rheumatology drugs. Benylysta was assigned a Prescription Drug User Fee Act target date of Dec. 9, 2010.

Benlysta is an investigational human monoclonal antibody drug. The drug is a formulation of Belimumab, which is the first investigational drug in a new class of drugs called BLyS-specific inhibitors. BLyS-specific inhibitors recognize and inhibit the biological activity of B-lymphocyte stimulator, or BLyS, which was discovered by HGS in 1996, according to the company’s website. In lupus, rheumatoid arthritis, and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies.

Benlysta successfully met its primary endpoint in two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE).

Organizations like The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations “are pleased with the U.S. Food and Drug Administration (FDA) Advisory Committee's vote,” according to a press release. The coalition said the new drug may offer new found hope for the first approved treatment option in more than 50 years.”

"The panel's recommendation may signal the historic breakthrough that lupus patients have long awaited," said Margaret G. Dowd, president of the LRI, an organization uniquely dedicated to funding innovative approaches to lupus research, in a press release. "This positive vote reinforces our community's resolve to increase the pace of scientific discovery and clinical development in lupus, made possible by the active participation of lupus patients in clinical trials."

"The results of both of Benlysta's phase III trials, BLISS-52 and BLISS-76, show that it reduces SLE disease activity, has a favorable safety profile and allows lupus patients to reduce their use of current treatment options that can cause serious adverse effects," said Benjamin Schwartz, M.D., Ph.D., a professor of clinical medicine at Washington University School of Medicine in St. Louis and a member of the LRI Scientific Advisory Board, in a press release. "Benlysta would be a welcome addition to the limited number of treatments available for people with lupus."

"It's exhausting to be on such a tedious schedule of medicines which cause so many side effects," said lupus patient, Sabrina Nixon, in a press release. "If approved, Benlysta will hopefully decrease the number of medications patients like me will need to stay alive."


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