Posted by Michael Wonder on 21 Nov 2018
GSK submits US regulatory filing to expand the use of Nucala in children with severe eosinophilic asthma
19 November 2018 - GSK today announced the filing of a supplemental biologics license application to the US FDA seeking an additional indication for the use of 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.
