GlaxoSmithKline (GSK) has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for an additional indication for Nucala (mepolizumab) as an add-on treatment for severe eosinophilic asthma in paediatric patients aged six to 11 years.
The submission is supported by a paediatric open-label study conducted in children aged six to 11 years that investigated pharmacokinetics, pharmacodynamics and long-term safety.
Mepolizumab, a humanised anti-IL5 monoclonal antibody, was approved in the US in 2015 for use as an add-on treatment for patients, aged 12 years or older, with severe asthma and an eosinophilic phenotype.
There are currently no targeted biologic therapies available in the US for patients with severe eosinophilic asthma who are as young as six years old.
Source: Company Press Release