Biopharmaceutical company Human Genome Sciences, Inc. (HGSI) announced Wednesday that the U.S. Food and Drug Administration or FDA, has approved Benlysta for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus who are receiving standard therapy.
Benlysta, an investigational human monoclonal antibody drug, is being developed by Rockville, Maryland-based Human Genome and British drug company GlaxoSmithKline (GSK, GSK.L) under a co-development and commercialization agreement entered into in 2006.The deal called for the two companies to share equally the phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the agreement.
"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," Human Genome Sciences President and CEO Thomas Watkins said in a statement.
Benlysta is the first Lupus treatment approved since 1958. Lupus is an incurable condition that causes the immune system to attack healthy cells, affecting about 5 million people worldwide.
Benlysta is expected to be available to physicians and patients before the end of March 2011, and is reportedly anticipated to generate sales of $3 billion by 2015.
In mid-November, the FDA Arthritis Advisory Committee had recommended the FDA to approve Benlysta for the indication. Following the Advisory Committee meeting, the FDA requested additional information from Human Genome and the company submitted it. In December 2010, the FDA extended the Prescription Drug User Fee Act (PDUFA) target date for the priority review of Benlysta to March 10, 2011.
Lupus is a chronic, life-threatening autoimmune disease, with symptoms of extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders.
Benlysta, or belimumab, is made available as a lyophilized powder in single-use vials for intravenous infusion only and must be reconstituted and diluted by a healthcare professional prior to administration.
Glaxo has also submitted a Marketing Authorization Application for Benlysta to the European Medicines Agency in June last year, and expects to receive the approval in the second half of 2011. Regulatory applications have also been submitted and are currently under consideration in Canada, Australia, Switzerland, Russia, Brazil and The Philippines.
HGSI closed Wednesday's regular trading session at $25.68, up $0.01 or 0.04 percent on a volume of 3.94 million shares, higher than the three-month average volume of 2.27 million shares.
GSK closed at $38.58, up $0.42 or 1.10 percent on a volume of 2.43 million shares. The stock gained a further $1.02 or 2.64 percent in after-hours trading.
GSK.L closed on the London Stock Exchange at 1,184.00 pence, up 17.98 pence or 1.54 percent on a volume of 8.45 million shares.
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