Key Committee Recommends Lupus Drug Approval

On November 16,a key Food and Drug Administration committee recommended approval of Benlysta,the Human Genome Sciences/GlaxoSmithKline drug for the treatment of systemic lupus erythematosus.
The Arthritis Advisory Committee,which made the recommendation,provides the FDA with independent expert advice on rheumatology drug products such as Benlysta.Its nonbinding recommendation normally carries a great deal of weight in the FDA's deliberations.
Benlysta is the first new treatment expressly for lupus in 50 years.The vote to recommend approval was hailed by patient advocates as a sign of hope.Benlysta is also the first in a new class of drugs,the BLys-specific inhibitors.
Since 2006,Human Genome and Glaxo have been developing Benlysta together,with Human Genome having lead responsibility for conducting Phase 3 trials.The companies will share equally in development costs,sales,marketing expenses and any profits pending final FDA approval.Analysts consider Benlysta a prospective blockbuster,worth billions of dollars.
Lupus is a chronic inflammatory disorder most common in black,Hispanic and Asian women.It causes the immune system to attack the body's own organs and tissues,resulting in effects ranging from joint pain to kidney damage.The disease is potentially life-threatening.Like another autoimmune disorder,multiple sclerosis,lupus is hard to diagnose and varies from patient to patient.
Human Genome is located in Rockville,Maryland,and Glaxo is based in London,England.
Human Genome Sciences(HGSI),GlaxoSmithKline(GSK)