GlaxoSmithKline (LSE/NYSE: GSK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years. If approved it would be the first targeted biologic therapy for the treatment of severe eosinophilic asthma in paediatric patients in Europe.
Dr Hal Barron, Chief Scientific Officer and President, R&DGSKsaid: ‘Ensuring our medicines have the broadest possible label is very important, as it allows us to help the greatest number of patients who may benefit. If approved Nucala could provide an additional option for younger patients in Europe who still struggle to control their asthma despite taking inhaled steroids and other controller medications. These are patients who are at high risk of asthma attacks, which can be a very frightening experience for anyone, especially young children.’
Asthma is the commonest chronic disease in childhood and severe asthma that is poorly responsive to current standard of care asthma treatments has been reported in approximately 4.5% of children with asthma.1
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission.
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