GlaxoSmithKline (NYSE:GSK) announced that the FDA approved 40 mg prefilled syringe of Nucala (mepolizumab) for children aged 6 – 11 years with severe eosinophilic asthma (SEA).
Nucala is indicated as an add-on, prescription maintenance treatment for at-home use or to be administered by a health care provider, the company said.
An estimated six million U.S. children suffer from asthma, with approximately 2.5-5% living with the severe form of the disease.
A monoclonal antibody that targets IL-5, Nucala was first approved by regulators in 2015 for severe eosinophilic asthma. Previously in Sep. 2020, the FDA greenlighted it for the hypereosinophilic syndrome (HES). Mepolizumab is currently undergoing studies in patients with chronic obstructive pulmonary disease (COPD).