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FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.
GlaxoSmithKline (GSK) announced that FDA has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin (IL)-5, for the treatment of severe eosinophilic asthma in children six years and older. The drug is the first targeted biologic to be approved for the condition in the six to 11-year age group in the United States, according to a Sept. 12, 2019 press release.
The approval was backed by a successful open-label study of children aged six to 11 years and living with the condition. The trial focused on the drug’s pharmacokinetics, pharmacodynamics, and long-term safety and concluded that the safety profile for pediatric patients aged six to 11 years was similar to a study conducted in patients aged 12 years and older.
Originally approved for the treatment of eosinophilic asthma in 2015, the drug prevents IL-5 from binding to its receptor on the surface of eosinophils to reduce blood eosinophils without completely depleting them. It has been approved in the US, Europe, and 20 other markets.
“Severe eosinophilic asthma in children is a complicated condition that can be extremely challenging to treat,” said Dr. Daniel Jackson, MD, department of pediatrics, University of Wisconsin, in the press release. “Nucala has made a difference for many adults and adolescents living with severe asthma. This approval is an important development, giving physicians like me a much-needed option to consider for our pediatric patients.”
“Children with severe eosinophilic asthma currently have limited treatment choices available to them. We believe this important new indication for Nucala is a significant development for these children and their families,” added Dr. Hal Barron, chief scientific officer and president, R&D, GSK, in the press release.