GlaxoSmithKline’s Nucala recommended for EU approval by CHMP

GlaxoSmithKline has announced that Nucala, its new treatment for severe refractory eosinophilic asthma, has been recommended for EU approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending Nucala's approval as an add-on treatment for severe refractory eosinophilic asthma in adult patients.

Positive results from the clinical study programme showed the benefits the drug can provide to severe refractory eosinophilic asthma patients with a history of recurrent exacerbations or dependency on systemic corticosteroids.

A final decision will be made by the European Commission before the end of 2015. To date, Nucala has not been approved anywhere in the world, although submissions in the US and Japan are under review.

Dave Allen, head of research and development for GlaxoSmithKline's respiratory therapy area unit, said: "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."