Benlysta, a GlaxoSmithKline hypodermic lupus drug, has been approved by the US FDA

Source: Bio Valley 2017-07-24 July 24, 2017 / Bio Valley/ --British pharmaceutical giant GSK recently announced that the US Food and Drug Administration (FDA) has approved the subcutaneous injection type (SC) bentlysta (belimumab) for active, auto antibody positive systemic lupus erythematosus (SLE) adult patients undergoing standard treatment SLE is the most common type of lupus, accounting for about 70% of all lupus cases It is a chronic, incurable autoimmune disease The body of patients produces autoantibodies to attack any tissue This approval also marks the approval of the first subcutaneous drug for the treatment of SLE Bentytsa is the first new drug approved to treat SLE in the past 50 years In the United States and the European Union, intravenous injection type (IV) bentysta was approved for marketing in 2011 for adult SLE patients with positive autoantibodies At present, benlysta is administered by intravenous infusion once every four weeks, and the dosage is adjusted according to body weight (10mg / kg), which takes about one hour The subcutaneous injection type of bentysta is administered by subcutaneous injection The product has two forms: single dose pre filling syringe and single dose automatic syringe After training, patients can inject subcutaneously by themselves This dosage form will provide an important treatment option for the patients with SLE The approval of subcutaneous injection of benlysta was based on the data of bliss-sc phase III critical study, which was carried out in patients with active auto antibody positive SLE The efficacy and safety of weekly subcutaneous injection of 200mg belimumab combined with standard therapy were evaluated Benlysta is the first specific inhibitor of B lymphocyte stimulator (BLyS), which can block the binding of soluble BLyS (a B cell survival factor) to BLyS receptor on B cell Benlysta does not directly bind to B cells, but by binding to BLyS, it can inhibit the survival of B cells (including self reactive B cells) and reduce the differentiation of B cells into plasma cells that produce immunoglobulins Benlysta can reduce the number of abnormal B lymphocytes that can aggravate the condition of lupus patients These abnormal B lymphocytes can cause the immune system to produce cells that attack blood vessels and other healthy tissues, thus causing lupus and other immune system diseases Systemic lupus erythematosus (SLE) is a chronic autoimmune disease If the disease is not controlled, it will lead to serious symptoms, including long-term organ damage and even premature death At the same time, the disease will have a huge impact on the physical and mental health of patients.