Treatment approved for young children with severe eosinophilic asthma

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma.

This treatment is the only targeted biologic to be approved for the condition in the six- to 11-year age group in the US. It is a 40mg dose subcutaneous injection. 

“Children with severe eosinophilic asthma currently have limited treatment choices available to them,” said Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK. “We believe this important new indication for Nucala is a significant development for these children and their families”.

The approval is supported by an open-label study, conducted in children aged six to 11 years and suffering from severe eosinophilic asthma, that investigated Nucala’s pharmacokinetics, pharmacodynamics and long-term safety.

Evidence from adequate and well-controlled trials in adults and adolescents also supported approval in this age group. The 52-week long-term phase of the study showed that the safety profile in paediatric patients aged six to 11 years was similar to the known safety profile in patients aged 12 years and older.

“Severe eosinophilic asthma in children is a complicated condition that can be extremely challenging to treat,” added Dr Daniel Jackson, MD, Department of Pediatrics, University of Wisconsin. “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 paediatric patients.”

Nucala (100mg dose subcutaneous injection) was first approved in 2015 as an add-on maintenance treatment for patients with severe eosinophilic asthma aged 12 years and older. The new approval extends the current indication in the US.