Nucala (mepolizumab) has been approved by the US Food and Drug Administration (FDA) for use in children as young as six years old who are living with severe eosinophilic asthma.
The GlaxoSmithKline drug is the only targeted biologic to be approved for the condition in the six to 11-year age group in the US. It was first approved in 2015 for severe eosinophilic asthma, and is a first-in-class monoclonal antibody that targets IL-5.
This approval (40mg dose subcutaneous injection) extends the current indication in the US for Nucala to patients aged six to 11 years.
The decision was supported by an open-label study conducted in children aged six to 11 years and suffering from a severe version of the condition, 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.
Dr Daniel Jackson, MD, Department of Pediatrics, University of Wisconsin, added: “Severe eosinophilic asthma in children is a complicated condition that can be extremely challenging to treat. 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”.
The treatment was also recently made available in two new formulations in the UK, a pre-filled pen and a pre-filled syringe, which may be self-administered by the patient. Patients prescribed the pre-filled formulations will now have the option to administer the treatment at home after being shown the injection technique, meaning that patients will no longer need to travel to an outpatient clinic or have a healthcare professional visit them at home to administer it.
Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller to prevent it from becoming “uncontrolled” or which remains “uncontrolled” despite therapy.