The phase III study is a multi-centre, multi-national study evaluating belimumab.
Randomised, double-blind study is designed to asses efficacy and safety profile of belimumab as a combination therapy with azathioprine for the maintenance of remission of ANCA associated Vasculitis (Granulomatosis with Polyangiitis (Wegener’s) or microscopic polyangiitis).
Belimumab belongs to a drug class known as BLyS-specific inhibitors.
In 2011, FDA had approved the drug to treat adult patients receiving standard therapy for active, autoantibody-positive systemic lupus erythematosus.
The European Commission also approved Belimumab in 2011 as an add-on therapy for adults with active, autoantibody-positive SLE with a high degree of disease activity in spite of standard therapy.