Belysta: the first drug approved to treat Lupus in 50 years.
Belimumab (Benlysta; Human Genome Sciences) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE) was recommended for approval in a 13 to 2 vote by the US Food and Drug Administration (FDA) Arthritis Advisory Committee on November 16th, 2010.
The background material on the FDA Web site, shows that the discussion focused on belimumab reducing disease activity in adult patients with active, autoantibody-positive SLE, for the proposed indication.
Belimumab (previously known as LymphoStat-B), is a fully human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-Lymphocyte stimulator (BLyS), also known as B cell activation factor of the TNF family (BAFF). The BLyS protein was discovered by researchers from the National Jewish Medical and Research Center and the University of Colorado and announced in 1999. BLyS plays a key role in B lymphocyte differentiation, survival and activation.
The Figure above from www.hgsi.com shows that BENLYSTA specifically binds to and inhibits the biological activity of BLyS, thus restoring the potential of autoantibody-producing B cells to undergo the normal process of programmed call death.
Belimumab is the first in a new class of drugs called BLyS-specific inhibitors, and the first medicine for lupus that has completed Phase 3 trials, involving 1,684 autoantibody-positive patients with SLE, with positive results.
Belimumab has been granted a priority review designation by the FDA (Food and Drug Administration, USA), which is granted to medications, that if approved, offer significant treatment advances or provide treatment when no proper therapy exists. The priority review designation speaks to the significant medical need of people living with lupus.
Human Genome Sciences (www.hgsi.com) is an emerging pharmaceutical company with the mission to predict, prevent, detect, treat and cure disease.
Why, in your opinion, it took 50 years to have a new treatment for Lupus?
Was Lupus’s treatment an unmet medical need?