Two pharmaceutical companies, Human Genome Sciences, Inc (HGS). and GlaxoSmithKline PLC ( GSK), jointly announced the FDA approval of BENLYSTA® a drug intended for the treatment of adult lupus patients who are currently receiving standard treatment.
The news release was simultaneously announced in Rockville, Maryland and London, England. In the news release the President and CEO of HGS, H. Thomas Watkins said
“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. We expect to have this novel therapy available to physicians and patients within about two weeks, and our entire organization looks forward to the positive impact we hope this new therapy will have for patients with systemic lupus.”
Lupus Foundation Applauds FDA's Decision
Speaking for the Lupus Foundation of America Sandra C. Raymond, President and CEO of the Foundation said
“This is a historic day for the millions of people with lupus and their families around the world who have waited more than 52 years for a treatment breakthrough for lupus. We at the LFA applaud the FDA’s decision to approve BENLYSTA®. BENLYSTA is the first drug ever to be specifically developed to treat lupus, and is a significant first step toward reaching our goal of developing an arsenal of new, safe, effective, and tolerable treatments. Today marks the beginning of a new era of improved diagnosis, prevention, and treatment for the disease.”
FDA approval brings the first new hope in 50 years
Lupus, or systemic lupus erythematosus, is a potentially fatal disease of the immune system. The disease attacks healthy tissue and affects joints, skin, kidneys and other organs. It is estimated that as many as 1.5 million Americans are currently suffering from lupus.
According to the FDA as disproportionate number of woman develop the disease and African American women are three times more likely to contract it than Caucasian women.
Lupus symptoms include swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue.
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