EC Awards Marketing Authorization to GSK’s Nucala

The European Commission has awarded British drugmaker GlaxoSmithKline marketing authorization for Nucala as an add-on treatment for severe refractory eosinophilic asthma in adults.

Nucala (mepolizumab) targets interleukin-5, a protein that aids in regulating the function of eosinophils.

The FDA approved Nucala on Nov. 4 as add-on maintenance treatment for severe asthma in patients 12 and older, and with an eosinophilic phenotype. The mAb is under regulatory review in Japan and other countries.