GlaxoSmithKline plc 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 the first and only approved 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 100mg 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.
