FDA approves Nucala (mepolizumab) to treat severe asthma- GSK

GlaxoSmithKline received approval from the 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 with an eosinophilic phenotype. Mepolizumab is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

Mepolizumab is the first 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 100 mg fixed dose subcutaneous injection every four weeks. Patients will receive mepolizumab 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. This is the first marketing authorisation granted for mepolizumab anywhere in the world.

Comment: The only drug approved for severe/allergic asthma is omalizumab (Xolair) from Novartis/Genentech. Roche has an asthma biologic in late-stage development, lebrikizumab. Data presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting suggested that the product's 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, also designed to inhibit IL-5, filed at the FDA with a decision due early in 2016. Another IL-5 antibody, benralizumab from AstraZeneca, is in Phase III trials.

Comment: Nucala is CHMP recommended in the EU.