Benlysta is an investigational human monoclonal antibody drug. It is the first in a new class of drugs called BLyS-specific inhibitors that recognise and inhibit the biological activity of B-lymphocyte stimulator, or BLyS, which was discovered by HGS in 1997.
Benlysta inhibits the biological activity of B-lymphocyte stimulator, or BLyS, a naturally occurring protein discovered by HGS, which is required for the survival and development of B-lymphocyte cells into mature plasma B cells.
Reportedly, Benlysta has successfully met its primary endpoint in two pivotal Phase 3 trials in systemic lupus. Following discussions with regulatory authorities, HGS and GSK plan to submit marketing applications in the US, Europe and other regions in the first half of 2010. HGS believes Benlysta has the potential to become the first new approved drug for people living with lupus in more than 50 years.
GSK said that the submission of the MAA was made in collaboration with Human Genome Sciences (HGS). Benlysta is being developed by GSK and HGS under a co-development and commercialisation agreement entered into in 2006.