By Fineline Cube 
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that it has received clearance from the US Food and Drug Administration (FDA) to market its 200 mg/mL autoinjector of Benlysta (belimumab). The approval is for subcutaneous injection in patients aged five years and older with active lupus nephritis (LN) who are receiving standard therapy.
Drug Mechanism
Benlysta is a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody (mAb). It binds to soluble BLyS to suppress the survival of B cells, including autoreactive B cells, and reduce their differentiation into immunoglobulin-producing plasma cells.
Approval Significance
Initially approved by the FDA for treating active systemic lupus erythematosus (SLE), Benlysta remains the only biologic approved for both SLE and LN—including pediatric populations—in over 50 years. This latest approval introduces a subcutaneous injection option for pediatric LN patients, enabling at-home treatment.-Fineline Info & Tech