Hot on the heels of its US approval GlaxoSmithKline’s asthma biologic Nucala has now also bagged clearance in the EU for a difficult-to-treat form of asthma.
The European Commission has green-lighted its use as an add-on therapy in adult patients with severe refractory eosinophilic asthma, in which over-production of eosinophils causes inflammation in the lungs that can affect the airways, limiting breathing and increasing the frequency of asthma attacks.
Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival, and Nucala (mepolizumab) is the first and only approved biologic therapy that targets IL-5 and stops it from binding to its receptor, thereby interrupting the inflammation pathway.
In one study underpinning the drug’s regulatory submissions (MEA115588), Nucala cut the frequency of clinically significant exacerbations of asthma by 47% versus placebo, while the 100mg dose cut the amount by 53%.
Around 60% of patients with severe asthma are thought to have eosinophilic airway inflammation, and will no doubt welcome news of a new option - widely considered a significant treatment advance that targets the underlying cause of the disease - to help manage their condition.
Despite taking high doses of inhaled medications many patients with severe eosinophilic asthma find it hard to control their condition, suffering from frequent asthma attacks that sometimes require hospitalisation.
“Many also take oral corticosteroids to control their symptoms, which we know can lead to side effects that patients often find very difficult to deal with,” said study investigator Ian Pavord, University of Oxford, adding: “To be able to offer these patients a treatment that specifically targets the underlying cause of their disease will be an important option”.