Nucala FDA approval : GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for Nucala (mepolizumab) for the treatment of severe eosinophilic asthma in children, aged six years and older.

Nucala, which is a monoclonal antibody that targets IL-5, is now the only targeted biologic to be approved by the FDA for the condition in the 6-11-year age group.

Tonya Winders – CEO and President of Allergy and Asthma Network, commenting on Nucala FDA approval, said: “As a mother of children who suffer from asthma, I know first-hand the huge impact it has on a family, from the constant worry about your child being hospitalised, to practical issues like arranging time off work to care for them.

“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.”

In 2015, Nucala 100mg dose subcutaneous injection was approved by the FDA as an add-on maintenance treatment for severe eosinophilic asthma in patients, aged 12 years and older.

The latest Nucala FDA approval is for 40mg dose subcutaneous injection for patients aged six to 11 years.

The GSK biologic has been approved in the European Union since August 2018 as an add-on treatment for severe eosinophilic asthma in patients aged six years and older.

GSK bags Nucala FDA approval for treatment of severe eosinophilic asthma in 6-11 years children. Photo courtesy of GSK group of companies.

Nucala FDA approval

Commenting on the latest Nucala FDA approval, Dr Hal Barron – Chief Scientific Officer and President, R&D at GSK, said: “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.”

The latest Nucala FDA approval is backed by data from an open-label study, held in children aged six to 11 years with severe eosinophilic asthma. The clinical trial evaluated the pharmacokinetics, pharmacodynamics and long-term safety of Nucala.

GSK said that proof from adequate and well-controlled clinical trials in adults and adolescents also resulted in the approval for the 6-11 years age group. The pharma giant said that the 52-week long-term phase of the study demonstrated that the safety profile in paediatric patients aged six to 11 years was in line with the known safety profile in patients aged 12 years and older.

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