GSK a step closer to gaining first approval for Nucala

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for UK pharma major GlaxoSmithKline's (LSE: GSK)mepolizumab, which will be commercialized under the brand name Nucala, as an add-on treatment for severe refractory eosinophilic asthma in adult patients.

This decision is based on the results from the clinical study program, which identified the patients that may be suitable for treatment with mepolizumab. Severe refractory eosinophilic asthma patients who participated in the Phase III trials were evaluated by eosinophil level and either a history of recurrent exacerbations or dependency on systemic corticosteroids. All patients were on high-dose inhaled corticosteroids plus another maintenance treatment.

Dave Allen, head, Respiratory Therapy Area Unit, R&D at GSK, 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.”