FDA approves new indication of GSK’s Nucala

The Food and Drug Administration has approved a 40 mg prefilled syringe of GSK’s Nucala (mepolizumab) for appropriate children aged 6 to 11 years old who have severe eosinophilic asthma.

Nucala can now be given by a child’s health care provider or administered at home by a caregiver once trained by a health care professional. Nucala is an add-on, prescription maintenance treatment for patients 6 years and older with severe eosinophilic asthma.

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Previously, children aged 6 to 11 years old received a dose of 40 mg Nucala using a solution that was mixed and administered in a physician’s office. Now, a child’s healthcare provider will determine if at-home administration is appropriate and if so, will provide instruction to a patient’s caregiver on how to properly administer and monitor for any allergic reactions. Nucala will be administered every four weeks whether at home or in the physician’s office.

“The needs of our patients and physicians continue to be the driving force of our innovation and new treatment offerings in the respiratory space,” said Tom Corbridge, GSK U.S. senior medical lead. “Being able to provide a treatment option administered at home for patients as young as 6 years old who are living with severe eosinophilic asthma, is an example of how our commitment to the community combined with clinical excellence can deliver on those needs.”

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Nucala already is approved as an add-on maintenance treatment of adult and pediatric patients aged 6 and older with severe asthma and with an eosinophilic phenotype. Nucala is not used to treat sudden breathing problems. 

The medication also is approved as an add-on maintenance treatment of CRSwNP in adults whose disease is not controlled with nasal corticosteroids; to treat adult patients with EGPA; and to treat adult and pediatric patients aged 12 years and older with HES for ≥6 months without an identifiable non-hematologic secondary cause.