FDA OKs Mepolizumab (Nucala) for Younger Children With Severe Asthma

Megan Brooks

September 12, 2019

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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