The European Commission (EC) has granted marketing authorisation for GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in adults.
Nucala is a biologic therapy that targets interleukin-5 (IL-5), which plays a major role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma.
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The drug is administered as a 100mg fixed-dose subcutaneous injection every four weeks, in addition to the patient’s normal respiratory medication, which includes high-dose inhaled corticosteroids plus additional medicines such as oral corticosteroids.
Nucala is currently approved for use in the 31 European countries covered by the European Medicines Agency (EMA).
GSK Global Respiratory Franchise head and senior vice-president Eric Dube said: "The marketing authorisation of Nucala in the EU is a significant treatment advance for appropriate asthma patients and reinforces GSK’s leadership in respiratory.
"We are proud that our work in this area, to better understand the specific role eosinophils play in severe asthma, has resulted in the licensing of mepolizumab as the first anti-IL-5 biological treatment. We aim to offer this medicine to patients as soon as possible."
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By GlobalDataThe approval is based on data from Phase IIb/III clinical development programme which investigated the efficacy and safety of mepolizumab in patients with severe asthma.
All patients in trials MEA115588 (MENSA) and MEA115575 (SIRIUS) had peripheral blood eosinophil levels greater than or equal to 150 cells/µL at initiation of treatment or greater than or equal to 300 cells/µL within the past 12 months.
University of Oxford professor Ian Pavord said: "Patients with severe refractory eosinophilic asthma are not the typical ‘asthma’ patients many people are familiar with. Despite taking high doses of inhaled medications, they struggle to control their asthma. They have particular problems with frequent asthma attacks and can 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. To be able to offer these patients a treatment that specifically targets the underlying cause of their disease will be an important option."
The programme involved nine studies and a total of 915 subjects with severe refractory eosinophilic asthma who received either a subcutaneous or an intravenous dose of mepolizumab during clinical studies of 24 to 52 weeks duration.
Image: GlaxoSmithKline headquaters in Brentford, London, England. Photo: courtesy of Maxwell Hamilton.
