FDA approves GlaxoSmithKline Nucala for treatment of pediatric severe eosinophilic granulocytes
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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recently, GlaxoSmithKline (GSK) announced that the U.SFood andDrug(http://Administration (
FDA(http://) has approved Nucala (mepolizumab) for the treatment of severe eosinophilic asthma in pediatric patients aged 6-11About Nucala
Nucala (100mg subcutaneous injection) is a human-induced anti-leukocyte interleukin-5 (IL-5) monoclonal antibody drug that was first approved by the FDA in 2015 for additional maintenance therapy for patients 12 years of age and older with severe eosinophilic glycecinthis approval (40mg subcutaneous injection) to extend Nucala's current u.Spopulation to patients aged 6-11In Europe, Nucala was approved in August 2018 as an additional therapy for pediatric patients aged 6-17 with severe eosinophilic granulocytic asthmaNucala's active ingredient is mepolizumab, an all-humanized monoclonal antibody specifically targeted at leukocyte interleukin 5 (IL-5)IL-5 is a cytokine that regulates the growth, activation, survival of eosinophils (white blood cells) and provides important signals for the migration of eosinophils from bone marrow to the lungs and other organsNucala binds to human IL-5, blocking the binding of IL-5 to eosinophil surface receptorsInhibiting the binding effect of IL-5 on the receptor in this way can reduce the level of eosinophils in the blood, tissues, and sputum, which in turn reduces the inflammation mediated by eosinophilsNucala was approved at the end of 2015 and is the world's first targeted IL-5 biotherapyso far, Nucala has been approved in the United States, Europe and 20 other markets as an additional maintenance therapy for patients with severe eosinophilic granulocytesin the United States, Japan, Canada and other markets, Nucala has also been approved as an additional maintenance therapy for the treatment of acidophilic granulocytes polyvascularitis (EGPA)
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