FDA approves Nucala

PharmaTimes | September 13, 2019

FDA approves Nucala
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”.

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Vaccines and vaccination efforts have effectively prevented many life-threatening or debilitating infectious diseases and are regarded as one of the greatest achievements in the field of public health.