FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

GSK’s Eosinophilic Asthma Biologic Approved by FDA for Children

Sept. 23, 2019
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The FDA approved GlaxoSmithKline’s Nucala (mepolizumab) has been approved by the FDA for use in children aged six to 11 years with severe eosinophilic asthma.

The agency’s approval for the 40mg dose subcutaneous injection was supported by a trial in children that showed the drug’s safety profile to be similar to the profile in patients 12 years of age and older.

Nucala (100mg dose subcutaneous injection) first received the agency’s approval in 2015 as an add on maintenance treatment for severe eosinophilic asthma patients.

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