GSK receives European marketing authorisation for Nucala® (mepolizumab) in 31 countries

GlaxoSmithKlineGlaxoSmithKline (LSE/NYSE: GSK) today announced that the European Commission has granted marketing authorisation for Nucala® (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in adult patients. As a result Nucala is now approved for use in the 31 European countries covered by the European Medicines Agency (EMA).

Nucala is the first and only approved biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma. It is administered as a 100mg fixed dose subcutaneous injection every four weeks in addition to the patient’s normal respiratory medication, which often comprises high-dose inhaled corticosteroids plus additional medicines including oral corticosteroids.

"The marketing authorisation of Nucala in the EU is a significant treatment advance for appropriate asthma patients and reinforces GSK's leadership in respiratory. We are proud that our work in this area, to better understand the specific role eosinophils play in severe asthma, has resulted in the licensing of mepolizumab as the first anti-IL-5 biological treatment. We aim to offer this medicine to patients as soon as possible." said Eric Dube, Senior Vice President & Head, GSK Global Respiratory Franchise.

The lead investigator of the first proof of concept trial for mepolizumab and an investigator for the Phase III MENSA study, Professor Ian Pavord, University of Oxford, commented: "Patients with severe refractory eosinophilic asthma are not the typical 'asthma' patients many people are familiar with. Despite taking high doses of inhaled medications, they struggle to control their asthma. They have particular problems with frequent asthma attacks and can require hospitalisation. Many also take oral corticosteroids to control their symptoms, which we know can lead to side effects that patients often find very difficult to deal with. To be able to offer these patients a treatment that specifically targets the underlying cause of their disease will be an important option."

The Phase IIb/III clinical development programme for mepolizumab investigated the efficacy and safety of mepolizumab in patients with severe asthma. All patients in studies MEA115588 (MENSA) and MEA115575 (SIRIUS) 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.

About asthma
Current estimates indicate that as many as 242 million people live with asthma worldwide. For many of these patients, existing therapies can provide adequate control of their symptoms if used appropriately. However, less than 5% of patients with asthma have severe refractory asthma and cannot achieve symptom control with existing therapies.

About severe asthma and eosinophilic inflammation
Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy. Severe asthma patients are also often categorised by long-term use of oral corticosteroids (OCS). In a sub-set of severe asthma patients, the over-production of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs that can affect the airways, limiting breathing and increasing the frequency of asthma attacks. Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival and provides an essential signal for the movement of eosinophils from the bone marrow into the lung. Studies suggest that approximately 60% of patients with severe asthma have eosinophilic airway inflammation.

About Nucala
Nucala is a monoclonal antibody that stops IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood, tissue and sputum eosinophil levels.

The mepolizumab phase II/III clinical development programme involved nine studies and a total of 915 subjects with severe refractory eosinophilic asthma who received either a subcutaneous or an intravenous dose of mepolizumab during clinical studies of 24 to 52 weeks duration. Three key clinical trials – DREAM (MEA112997), MENSA (MEA115588) and SIRIUS (MEA115575) – have established the efficacy and safety profile of Nucala for severe refractory eosinophilic asthma patients.

The Marketing Authorisation Application for Nucala was submitted to the EMA in November 2014 and was approved on 2 December 2015.

Nucala was approved in the US on 4 November 2015 as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Full US Prescribing Information is available at US Prescribing Information Nucala. Regulatory applications in a number of other countries, including Japan, have been submitted and are under review. Further submissions are planned during the course of 2016.

Nucala® is a registered trade mark of the GSK group of companies

GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

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