The Arthritis Advisory Committee of the U.S. Food and Drug Administration has voted 13-2 to recommend approval of Benlysta (belimumab) for the treatment of lupus -- specifically, autoantibody-positive patients with active systemic lupus erythematosus. Benlysta, which is being co-developed by Human Genome Sciences and Glaxosmithkline, is the first in a new class of drugs known as BLyS-inhibitors. If approved, Benlysta will be the first new treatment for lupus approved in 5 decades.
In clinical trials, Benlysta was marginally better at easing symptoms than placebo, but the drug did allow patients to decrease steroid use. Benlysta is a monoclonal antibody that targets a protein referred to as B-lymphocyte stimulator (BLyS). The FDA is not required to follow the advice of the committee but usually does. Their decision may come before the end of the year.
Related Resources:
- Lupus Screening Quiz
- 10 Things You Should Know About Lupus
- What Is a Monoclonal Antibody?
- Benlysta Passed Second Clinical Trial (11/2009)
- Benlysta Shows Promise for Lupus (7/2009)
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