EU approves Nucala (mepolizumab) as a treatment for severe refractory eosinophilic asthma- GSK

GlaxoSmithKline announced that the European Commission has granted marketing authorisation for Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in adult patients. As a result Nucala is now approved for use in the 31 European countries covered by the European Medicines Agency (EMA).

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 in addition to the patient’s normal respiratory medication, which often comprises high-dose inhaled corticosteroids plus additional medicines including oral corticosteroids.

Comment: Roche has an asthma biologic in late-stage development which is lebrikizumab. Data presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting suggested that its effect on asthma attacks in severe asthmatics who expressed high levels of the protein periostin may have been "unprecedented" in two Phase IIb trials. Teva has an asthma biologic, reslizumab, designed to inhibit IL-5 and another another IL-5 antibody in Phase III trials is benralizumab from AstraZeneca.