DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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3 mar 2013
GSK, the company said it has kicked off a Phase III trial of its lupus drug Benlysta (belimumab) in patients with ANCA (Anti-neutrophil Cytoplasmic Antibodies) positive vasculitis, a condition characterised by inflammation of the blood vessels.
The multicentre, multi-national, randomised, double-blind study will assess the drug’s efficacy and safety in combination with azathioprine for the maintenance of remission in patients with a particular type of vascultitic disease called ANCA associated Vasculitis (Granulomatosis with Polyangiitis (Wegener’s) or microscopic polyangiitis).
Belimumab (trade name Benlysta, previously known as LymphoStat-B) is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator (BLyS) B cells are responsible for part of the normal immune response, and also for the over-aggressive immune response in autoimmune diseases like systemic lupus erythematosus (SLE).
Belimumab is approved in the United States, Canada and Europe for treatment of SLE. However, the major phase III trials excluded the more severe cases of SLE with kidney and brain damage, so its effectiveness has not been demonstrated in those cases. A Phase III study for SLE patients with kidney disease is now recruiting.
U.S. F.D.A. reviewers were concerned that belimumab is only “marginally” effective, and that there were more deaths in the treatment group.
Phase II trials of belimumab for rheumatoid arthritis were unsuccessful. Phase II trials for Sjögren’s Syndrome were more successful.
Belimumab was developed by Human Genome Sciences (HGS) and Cambridge Antibody Technology. GlaxoSmithKline acquired HGS, took belimumab through Phase III clinical trials, and markets belimumab.
New Drug Approvals 