The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for GlaxoSmithKline’s (GSK) new anti-IL5 biological Nucala (mepolizumab) to treat adults with severe refractory eosinophilic asthma.
CHMP gives its recommendations for marketing authorisation of mepolizumab to the European Commission (EC), which is expected to take a final decision by the end of this year.
The company submitted a marketing authorisation application (MAA) for mepolizumab to the EMA last November.
The CHMP positive opinion is based on the results from the clinical study programme, which identified the patients that may be suitable for treatment with mepolizumab.
The Phase III trial programme included severe refractory eosinophilic asthma patients and they were evaluated by eosinophil level and either a history of recurrent exacerbations or dependency on systemic corticosteroids.
In these trials, all patients were on high-dose inhaled corticosteroids plus another maintenance treatment.
If approved, mepolizumab would be the first anti-IL5 biological treatment approved for use in these patients.
Administered through a 100mg subcutaneous injection every four weeks, mepolizumab is a monoclonal antibody that recognises Interleukin 5, which stimulates B cell growth and increases immunoglobulin secretion and the number of eosinophils.
The drug also prevents IL-5 from binding to its receptor on the surface of eosinophils.
GSK respiratory therapy area unit head Dave Allen said: "For these difficult-to-treat patients, there are very limited treatment options.
"Many struggle to control their asthma even when taking high doses of inhaled therapies and are often reliant on daily oral corticosteroids, which can cause serious long-term side-effects.
"This positive opinion brings us a step closer to adding a targeted biologic therapy, specifically developed for patients with severe eosinophilic asthma, to our respiratory portfolio."
A total of 915 patients with severe asthma were included in the Phase III clinical development programme and they were given mepolizumab in addition to standard of care.
According to the company, all patients in trials MEA115588 and MEA115575 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.
Mepolizumab is not currently approved for use anywhere in the world, while regulatory applications in a number of other countries, including the US and Japan, have been submitted and are under review.
The company intends to make further submissions later this year and in 2016.
Image: GlaxoSmithKline headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.