FDA OKs GSK’s Biologic Drug for Severe AsthmaBy
GlaxoSmithKline plc has received approval from the US Food and Drug Administration (FDA) for its biologics license application (BLA) for Nucala (mepolizumab) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
Nucala is a biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma. It is administered as a 100-mg fixed-dose subcutaneous injection every four weeks. Patients will receive Nucala in addition to their normal medications for severe asthma, which include high-dose inhaled corticosteroids plus at least one additional asthma control medicine, and may include oral corticosteroids.