The safety data for NUCALA is based upon 1 open-label clinical trial that enrolled 36 patients with severe asthma aged 6 to 11 years. Patients received 40 mg (for those weighing <40 kg) or 100 mg (for those weighing ≥40 kg) of NUCALA administered subcutaneously once every 4 weeks. Pati...
4.5-YEAR OPEN-LABEL STUDY5,6 Mean blood EOS levels: 240 cells/μL at baseline; ~40-50 cells/μL on NUCALA treatment.6 Results are descriptive. The clinical significance of these pharmacodynamic data is unknown. See data on normal EOS levels ...
In September 2019, the U.S. FDA approved Nucala for use in children as young as 6 years of age who have severe eosinophilic asthma. FDA approval is based on an open-label clinical trial (NCT02377427) which was conducted in 36 children aged 6 to 11 years who have severe asthma. Based ...
GlaxoSmithKline plc (GSK) today announced the filing of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking an additional indication for the use of Nucala (mepolizumab) as an add-on treatment for severe...