Lupus Drug Made Priority

The FDA has granted a priority review designation to the lupus drug Benlysta,a joint project of Human Genome Sciences and its partner GlaxoSmithKline.Benlysta is the first medicine for systemic lupus erythematosus,the most common form of the disease,to complete Phase 3 trials with positive results,said Dr.Carlo Russo,Senior Vice President,Biopharm Development with GSK.The priority review designation is given to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists.European marketing authorization is also being sought for Benlysta.
Lupus is an autoimmune disease that is most common among women of Asian,African or Hispanic heritage.It is a chronic inflammatory disorder caused by the body's immune system attacking its own organs and tissues.Like multiple sclerosis,lupus has a wide variety of symptoms and is difficult to diagnose.Most cases are mild with episodic flare-ups.Symptoms range from fatigue and fever to joint pain and skin lesions.Lupus can be fatal,damaging the kidneys,causing atherosclerosis,or hardening of the arteries,and possibly even the cancer non-Hodgkin's lymphoma.The American College of Rheumatology has compiled a checklist of 11 clinical and laboratory criteria to assist with diagnosis.
HGSI and GSK entered into a co-development and commercialization agreement for Benlysta in 2006.They will share equally in development costs,sales,marketing expenses and profits,pending approval.
Human Genome Sciences is based in Rockville,Maryland and GlaxoSmithKline is a British firm.
Human Genome Sciences(HGSI),GlaxoSmithKline(GSK)