Drugs Xagena
The US Food and Drug Administration ( FDA ) has approved Biologics License Application ( BLA ) for Nucala ( Mepolizumab ) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
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.
Patients receive 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.
Patients who were shown to benefit from treatment with Mepolizumab in the phase III clinical trials were those with blood eosinophil levels of 150 cells/mcL or greater just prior to treatment.
Nucala is a monoclonal antibody, which stops IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood eosinophil levels.
The Mepolizumab phase II/III clinical development programme has involved nine studies and over 1,300 patients. Three key clinical trials – DREAM, MENSA and SIRIUS – have established the efficacy and safety profile of Nucala.
Current estimates indicate that as many as 242 million people live with asthma worldwide. It is estimated that in the US asthma affects 25.7 million individuals. For many of these patients, existing therapies can provide adequate control of their symptoms if used appropriately. However approximately 5% of patients with asthma cannot achieve symptom control with existing therapies.
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 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. ( Xagena )
Source: GSK, 2015
XagenaMedicine_2015
