GlaxoSmithKline recently announced that the company submitted regulatory submissions, both in US and Europe, for Mepolizumab as a maintenance treatment for severe eosinophilic asthma. The news could have promising implications for those suffering with asthma.
In eosinophilic asthma, there is an accumulation of eosinophils — a type of white blood cell of the immune system important for body’s defense against parasitic infections. However, in allergic reactions such as asthma, eosinophils are often associated with increased risk of risk of severe asthma exacerbations.
The submission involved a Biologics License Application submitted to the US FDA (Food and Drug Administration) and a Marketing Authorization Application to the European Medicines Agency for the use of mepolizumab as a maintenance treatment in patients who are at least 12 years old that suffer from severe eosinophilic asthma (for the US) and adding a history of exacerbations and/or dependency on systemic corticosteroids (for Europe).
Mepolizumab is a monoclonal antibody specific for IL-5. Eosinophils are the main cells that respond to IL5 signaling due to a receptor on its surface. Thus, Mepolizumab binds IL-5, preventing its binding to the surface of eosinophils. Since IL-5 is the primary signal for eosinophil growth, activation, and survival, and promotes eosinophil migration to the lungs, mepolizumab administration is effective because it results in decreased levels of eosinophil levels in blood, tissue, and sputum. The data supporting the submissions to US and European regulatory agents came from previous severe asthma clinical trials, namely phase III MENSA1 and SIRIUS2 and also phase IIb/III DREAM3, published in the New England Journal of Medicine and The Lancet, respectively.
Dave Allen, Head, Respiratory Therapy Area Unit, R&D, commented, “Severe asthma can have serious health consequences and for patients with elevated eosinophil levels whose disease remains uncontrolled despite taking medication, there are few treatment options. With the regulatory filings announced today, we are taking a further step towards making mepolizumab available for this difficult-to-treat group.”