The US Food and Drug Administration (FDA) has expanded the indication for mepolizumab (Nucala, GlaxoSmithKline) to children as young as 6 years old with severe eosinophilic asthma.
Mepolizumab subcutaneous injection was first approved in the United States in 2015 as an add-on maintenance treatment for patients with severe asthma who were aged 12 years or older and who had an eosinophilic phenotype.
Expanded approval in children aged 6 to 11 years is supported by an open-label study conducted in that age group that investigated mepolizumab's pharmacokinetics, pharmacodynamics, and long-term safety, the company said in a news release.
Evidence from trials in adults and adolescents also supported approval in this age group. The safety profile of mepolizumab in children as young as 6 years was similar to the known safety profile in patients aged 12 years or older, the company said.
"Severe eosinophilic asthma in children is a complicated condition that can be extremely challenging to treat," Daniel Jackson, MD, Department of Pediatrics, University of Wisconsin, Madison, said in the 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," he said.
"Having Nucala approved as the first biologic for treating severe eosinophilic asthma in this young age group represents a significant step forward for the asthma community," added Tonya Winders, CEO and president, Allergy and Asthma Network.
In June, the FDA approved two new methods for administering mepolizumab ― an autoinjector, and a prefilled safety syringe, which patients or caregivers can use to administer the drug at home once every 4 weeks, as reported by Medscape Medical News.
Mepolizumab is also approved in the United States for adults with eosinophilic granulomatosis with polyangiitis.
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Cite this: FDA OKs Mepolizumab (Nucala) for Younger Children With Severe Asthma - Medscape - Sep 12, 2019.
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