GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval as First Biologic for Severe Eosinophilic Asthma in Children Aged 6-11yrs.

Shots:

• The US FDA’s approval follows the open-label study evaluating PK/PD and long-term safety of Nucala (40mg, SC) in children with severe eosinophilic asthma aged 6 to 11yrs. The approval is also supported by results of well-controlled studies assessing Nucala in adults and adolescents
• The 52wks. long term study of Nucala in pediatric patients aged 6-11yrs. is similar to a safety profile in patients aged ≥12yrs.
• Nucala (100mg, SC) is mAb targeting IL-5, approved as an add-on maintenance therapy for severe eosinophilic asthma patients aged ≥12yrs. in 2015. In Aug 2018, Nucala has received approval as an add-on treatment for severe eosinophilic asthma in patients aged 6-11yrs. in the EU

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