GSK

The US Food and Drug Administration (FDA) has granted approval for GlaxoSmithKline’s biologics licence application (BLA) for Nucala (mepolizumab), which is designed to treat patients aged 12 years and older with severe asthma and an eosinophilic phenotype.

The company said that Nucala is not approved to treat other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

The drug is indicated for patients with a history of severe asthma attacks despite receiving their current asthma medicines.

Nucala is administered as a 100mg fixed dose subcutaneous injection every four weeks. It targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, a type of white blood cell that contributes to the development of asthma.

The company said that patients will be given Nucala in addition to their normal medications for severe asthma, which include high-dose inhaled corticosteroids plus at least one additional asthma control medicine, and may include oral corticosteroids.

GSK Global Respiratory Franchise senior vice-president and head Eric Dube said: "Following approval, GSK can now offer, as part of our overall respiratory portfolio, a first-in-class biologic treatment for severe asthma patients whose condition is driven by eosinophilic inflammation.

"Our research has allowed us to better understand the specific role eosinophils play in severe asthma. We are proud of our contribution to this emerging area of science that has led to the approval of the first anti-IL5 treatment. We aim to offer this medicine to patients as soon as possible."

The safety and efficacy of Nucala were established in three double-blind, randomised, placebo-controlled trials (Dream, Mensa and Sirius) in patients with severe asthma on currently available therapies.

Patients who were shown to benefit from treatment with mepolizumab in the Phase III trials were those with blood eosinophil levels of 150 cells/mcL or greater just prior to treatment.

"The prospect of a treatment that can specifically target the underlying cause of the disease for patients whose condition is driven by eosinophilic inflammation is exciting."

University of Oxford lead investigator of the first proof of concept trial for mepolizumab and an investigator for the Phase III MENSA study professor Ian Pavord said: "Severe asthma is a debilitating condition in which patients are at high risk of frequent and serious asthma attacks.

"Half of all severe asthma patients have at least one urgent care visit per year. As a clinician, the prospect of a treatment that can specifically target the underlying cause of the disease for patients whose condition is driven by eosinophilic inflammation is exciting."

In these trials, patients were given Nucala or a placebo every four weeks as an add-on asthma treatment.

Compared with placebo, patients with severe asthma receiving Nucala had fewer exacerbations requiring hospitalisation and/or emergency department visits, and a longer time to the first exacerbation.

The mepolizumab Phase II/III clinical development programme included nine studies and more than 1,300 patients.

In September, GSK received positive opinion from the European Medicines Agency ‘s Committee for Medicinal Products for Human Use (CHMP) for Nucala to treat patients with severe refractory eosinophilic asthma.


Image: GlaxoSmithKline headquaters in Brentford, London, England. Photo: courtesy of Maxwell Hamilton.