FDA approves Nucala (mepolizumab) 40 mg prefilled syringe for children with severe eosinophilic asthma

发布时间： 2022-01-31 阅读：433次

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Jan. 24, 2022----GlaxoSmithKline plc (GSK) announced that the US Food and Drug Administration (FDA) has approved a 40 mg prefilled syringe of Nucala (mepolizumab) for appropriate children aged 6 to 11 years old who have severe eosinophilic asthma (SEA). Nucala can now be given by a child’s health care provider or administered at home by a caregiver once trained by a health care professional. Nucala is an add-on, prescription maintenance treatment for patients 6 years and older with severe eosinophilic asthma.

Previously, children aged 6 to 11 years old received a dose of 40 mg Nucala using a solution that was mixed and administered in a physician’s office. Now, a child’s healthcare provider will determine if at-home administration is appropriate, and if so, will provide instruction to a patient’s caregiver on how to properly administer and monitor for any allergic reactions. Nucala will be administered every four weeks whether at home or in the physician’s office.

Asthma is the most common chronic disease in children.  It is estimated that 6 million children in the US are living with asthma. Approximately 2.5-5% of these cases are characterized as severe. Severe asthma can have an impact on a patient’s quality of life, as their asthma symptoms can remain uncontrolled, despite high-dose standard treatments. This can leave patients at an increased risk of asthma attacks.