GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Nucala (mepolizumab) to treat children as young as six years old living with severe eosinophilic asthma.
Nucala is claimed to be the only targeted biologic to secure approval for the condition in the six to 11-year age group in the US.
The FDA approval of Nucala was based on data from an open-label study carried out in children aged six to 11 years living with severe eosinophilic asthma.
GSK’s study assessed pharmacokinetics, pharmacodynamics and long-term safety of Nucala. The data from adequate and well-controlled trials in adults and adolescents also helped to secure approval in this age group.
The 52-week phase of the study demonstrated that the safety profile in paediatric patients aged six to 11 years was similar to the safety profile in patients aged 12 years and older, said the company.
In 2015, the company first secured approval for Nucala (100mg dose subcutaneous injection) as an add-on maintenance treatment for patients aged 12 years and older with severe eosinophilic asthma. The approval for the 40mg dose subcutaneous injection expands the current indication in the US for Nucala to patients aged six to 11 years.
Since August 2018, Nucala has been approved for use as an add-on treatment for severe eosinophilic asthma in patients aged six years and older in the EU.
Mepolizumab is the first-in-class monoclonal antibody, which targets IL-5. It is believed to work by blocking IL-5 from binding to its receptor on the surface of eosinophils.
The inhibition of IL-5 binding in this process will help reduce blood eosinophils without completely depleting them.
Mepolizumab has been approved as an add-on maintenance treatment for patients with severe eosinophilic asthma in the US, Europe and in more than 20 other markets.
GSK chief scientific officer and R&D president Dr Hal Barron 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.”