GSK gets European approval for asthma treatment Nucala
pharmafile | December 3, 2015 | News story | Research and Development | GSK, Nucala, asthma
GlaxoSmithKline has received marketing authorisation from the European Commission for Nucala as an add-on treatment for severe refractory eosinophilic asthma in adult patients.
The European approval follows GSK’s announcement yesterday that Nucala (mepolizumab) is now also available by prescription in the US. The FDA approved the treatment for the same indication November 4.
Mepolizumab is the first and only 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 100mg fixed dose subcutaneous injection every four weeks in addition to the patient’s normal respiratory medication, which often comprises high-dose inhaled corticosteroids plus additional medicines including oral corticosteroids.
“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.” says Eric Dube, senior vice president and head of GSK’s global respiratory franchise.
The lead investigator of the first proof of concept trial for mepolizumab and an investigator for the Phase III MENSA study, the University of Oxford’s Professor Ian Pavord, welcomed the new treatment option for sufferers of the condition.
He comments: “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.”
Joel Levy
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