Human Genome Sciences and GlaxoSmithKline announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve BENLYSTA® (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE)
ROCKVILLE, MD, USA and LONDON, UK | November 16, 2010 | Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve BENLYSTA® (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE).
The FDA Arthritis Advisory Committee is convened to provide the FDA with independent expert advice on a broad range of issues related to rheumatology drug products. The committee provides non-binding recommendations for consideration by FDA, with the final decision on approval made by FDA. The FDA has assigned BENLYSTA a Prescription Drug User Fee Act target date of December 9, 2010.
Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. HGS and GSK are developing belimumab under a definitive co-development and co-commercialization agreement entered into in 2006. Under the agreement, HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.
ABOUT GLAXOSMITHKLINE
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease.
ABOUT HUMAN GENOME SCIENCES
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to medinfo@hgsi.comThis e-mail address is being protected from spam bots, you need JavaScript enabled to view it or by calling HGS at (877) 822-8472. HGS, Human Genome Sciences, and BENLYSTA are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.
SOURCE: HUMAN GENOME SCIENCES
Post Views: 44
Human Genome Sciences and GlaxoSmithKline announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve BENLYSTA® (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE)
ROCKVILLE, MD, USA and LONDON, UK | November 16, 2010 | Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve BENLYSTA® (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE).
The FDA Arthritis Advisory Committee is convened to provide the FDA with independent expert advice on a broad range of issues related to rheumatology drug products. The committee provides non-binding recommendations for consideration by FDA, with the final decision on approval made by FDA. The FDA has assigned BENLYSTA a Prescription Drug User Fee Act target date of December 9, 2010.
Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. HGS and GSK are developing belimumab under a definitive co-development and co-commercialization agreement entered into in 2006. Under the agreement, HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.
ABOUT GLAXOSMITHKLINE
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease.
ABOUT HUMAN GENOME SCIENCES
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to medinfo@hgsi.comThis e-mail address is being protected from spam bots, you need JavaScript enabled to view it or by calling HGS at (877) 822-8472. HGS, Human Genome Sciences, and BENLYSTA are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.
SOURCE: HUMAN GENOME SCIENCES
Post Views: 44
