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(Mepoli monoanti) has been approved by the U.S. Food and Drug Administration (FDA) for use in children under the age of 6 with severe eosinophilic asthma.
GlaxoSmithKline's drug is the only targeted biologic agent approved for the disease in the U.S. age group of 6 to 11. It was first approved in 2015 to treat severe eosinophilic asthma and is a first-class monoclonal antibody against erythrin-5.
This approval (40 mg dose of subsurfic injection) extends the current adaptation of Nucara in the United States to patients between the ages of 6 and 11.
The decision was supported by an open study of children aged 6 to 11 with serious illnesses, which looked at pharmacodynamics, pharmacodynamics and long-term safety in Nucara.
Evidence from well-controlled trials in adults and adolescents also supports recognition in this age group.
Daniel Jackson, M.D., Paediatrics, University of Wisconsin, added: "Severe eosinophilic asthma in children is a complex disease that can be challenging to treat. Nucala has made a difference for many adults and adolescents with severe asthma. This approval is an important development that gives doctors like me a much-needed choice to consider our pediatric patients.
”
the treatment has also recently been introduced in the UK with two new formulations, one for pre-charged pens and the other for pre-filled syringes, which can be used by patients themselves. Patients who prescribe pre-filled preparations can now choose to be treated at home after receiving the injection technique, which means that patients no longer need to go to the clinic or have a healthcare professional treat them at home.
Severe asthma is defined as asthma that requires high-dose inhalation of corticosteroids (ICS) plus a second controller to prevent it from becoming uncontrolled or remains uncontrolled despite treatment. (cyy123.com)