GlaxoSmithKline’s non-inhaled, biologic therapy for a difficult-to-treat form of severe asthma has cleared the last major hurdle before European clearance.
Mepolizumab, which is to be sold under the brand name Nucala, has been recommended for approval by the Medicines and Healthcare products Agency, as an add-on treatment for severe refractory eosinophilic asthma in adult patients.
“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,” noted Dave Allen, head of GSK’s Respiratory Therapy Area Unit, R&D.
Administered by subcutaneous injection every four weeks, mepolizumab is a monoclonal antibody that inhibits interleukin 5 and thus reduces the number of eosinophils in the tissues, blood and sputum, high levels of which can trigger both asthma and symptom exacerbations.
In study MEA115588, mepolizumab 75mg cut the frequency of clinically significant exacerbations of asthma by 47% versus placebo, while the 100mg dose cut the amount by 53%.
If approved, the drug would be the first anti-IL5 biologic cleared for use in this patient population. A final decision is expected by the end of 2015.