On Wednesday, the U.S. Food and Drug Administration approved a drug called Benlysta (belimumab). It is the first new lupus drug to be approved in 56 years, according to FDA records. Benlysta is intended for those patients who suffer from lupus and are already undergoing the standard cocktail treatment of corticosteroids, non-steroid anti-inflammatories, anti-malarials and immuno-suppressive drugs.
Benlysta fact sheet
Created by the biotech company Human Genome Sciences Inc., Benlysta is marketed as a human monoclonal antibody drug, the first in a new class of drugs called BlyS-specific inhibitors. These drugs suppress biological activity within the B-lymphocyte stimulator (BlyS, or B-cell activating factor), a protein that plays an important role in the expression, proliferation and differentiation of B cells (white blood cells important in immune response within the bone).
Administered intravenously to patients with mild to moderate cases of lupus, Benlysta targets abnormal B cells that are known to attack healthy tissue. As lupus is often associated with other problems like high cholesterol, high blood pressure and other infections, a variety of other medications are typically also required for treatment.
Lupus, which causes the immune system to attack healthy skin, joints and internal organs, has traditionally been difficult to treat. Symptoms include swelling, joint pain, sensitivity to light, fever, chest pain, hair loss and fatigue. There is no cure, and the disease can be fatal without treatment. Before the development of Benlysta, drugs such as aspirin, Plaquenil and corticosteroids (anti-inflammatory/immuno-suppressant) were used to treat lupus, with sporadic effectiveness and the potential for serious side effects such as severe bone loss.
As many as 1.5 million people in the U.S. suffer from lupus, and 5 million worldwide. Doctors believe it is inherited, rather than contracted, but other unknown factors likely exist. Women between the ages of 15 and 44 are most prone, and African-American women are three times more likely to develop lupus than Caucasian women.
The Benlysta difference
Dr. Curtis Rosebraugh, whose FDA office reviewed Benlysta, points to the new drug’s ability to manage symptoms.
“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,” he said.
Human Genome Sciences, Inc., and GlaxoSmithKline share a co-development and commercialization agreement for Benlysta in which the two companies will split profits. This is significant in that annual global sales are projected to top $3 billion by 2015, reports Thomson Reuters.
For more information on Benlysta, lupus and related conditions, the National Institute of Arthritis and Musculoskeletal and Skin Diseases provides the following contact info:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
1 AMS Circle
Bethesda, MD 20892-3675
Toll Free: 877-22-NIAMS (226-4267)
NIAMSinfo (at) mail.nih.gov
Human Genome Sciences, Inc: http://www.hgsi.com/BENLYSTA.html
National Institute of Arthritis and Musculoskeletal and Skin Diseases: http://www.niams.nih.gov/Health_Info/Lupus/lupus_ff.asp
U.S. Food and Drug Administration: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246489.htm
Wikipedia entry for lupus: http://en.wikipedia.org/wiki/Systemic_lupus_erythematosus
Benlysta will not work for everyone
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