GSK Files With FDA And EMA For Mepolizumab In Asthma
GlaxoSmithKline announced that it has filed regulatory applications with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for mepolizumab as maintenance treatment for severe eosinophilic asthma.
Mepolizumab is an investigational humanized IgG1 monoclonal antibody designed to specifically bind to IL-5 to prevent it from binding to its receptor found on the surface of eosinophils. The drug’s mechanism of action helps reduce the levels of blood, tissue, and sputum eosinophil. Eosinophils or white blood cells tend to accumulate in lung tissues in asthma. It is generally known that eosinophil levels correlate with the severity and frequency of asthma exacerbations. Interleukin-5 (IL-5) is directly implicated in the rise of eosinophil levels, which makes it a therapeutic target for the maintenance treatment of asthma.
GSK submitted a Biologics License Application to the FDA seeking approval for mepolizumab as an add-on maintenance therapy for severe eosinophilic asthma in patients 12 years old and above with documented disease exacerbations. A Marketing Authorization Application (MAA) was submitted to the EMA for mepolizumab as add-on treatment for adults with severe eosinophilic asthma who have a history of exacerbation and/or reliance on systemic corticosteroids.
Dave Allen, Head, Respiratory Therapy Area Unit, R&D at GSK, said, “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.”
The applications are supported by the Phase 3 MENSA and SIRIUS studies which studied patients with blood eosinophils of either 150 or more cells per microlitre at the beginning of the treatment or 300 or more cells per microlitre in the last 12 months. The company is also investigating mepolizumab in eosinophilic chronic obstructive pulmonary disease (COPD) and Eosinophilic Granulomatosis with Polyangiitis (EGPA).
GSK said it anticipates more regulatory filings this year and in 2015 for mepolizumab.