FDA approves Nucala prefilled syringe for children with severe asthma

By Jane Byrne contact

- Last updated on GMT

© GettyImages/Jakovo
© GettyImages/Jakovo

Related tags: Glaxosmithkline, Asthma, at-home administration, Pediatrics

GlaxoSmithKline plc (GSK) says the US Food and Drug Administration (FDA) has approved its anti-IL-5 biologic Nucala (mepolizumab) in a 40 mg pre-filled syringe for children aged 6 to 11 years old with severe eosinophilic asthma (SEA).

This is the first approved anti-IL-5 biologic therapy option for at-home administration in both pediatric and adult populations living with SEA, said the company.

Previously, children aged 6 to 11 years old received a dose of 40 mg of that medication using a solution that had to be mixed and administered in a physician’s office every four weeks.

Flexibility in drug administration 

Dr Tom Corbridge, GSK US senior medical lead, spoke to us about the expansion of the Nucala label and what it would mean for children living with SEA.

This approval really provides caregivers and the patients the ability to choose whether they receive the medication in office, which is the way it has currently been given since its approval in 2019 in pediatrics, or to opt for at-home administration. I think to have that choice is a breakthrough. It will really simplify the administration [of this therapy] for some families, particularly in the era of COVID-19.”

GSK, he added, is committed to meeting the needs of patients and families, to ensuring flexibility on how drugs are administered.

“Asthma in pediatrics is very disruptive, to the patient, of course, in terms of symptoms but it is often very hard on the families, the caregivers at home, as it can disrupt family life, and, part of that, is the need to see physicians on a regular basis, that can be very challenging for schedules.”

A child’s healthcare provider will determine if at-home administration is appropriate, and if so, will provide instruction to the child’s caregiver on how to properly administer and monitor for any allergic reactions, he said. The drug is given every four weeks, whether at home or in the doctor’s office.

UK production 

Nucala is manufactured at GSK’s production site in Barnard Castle in the UK.

Indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype, Nucala was first approved in 2015 for SEA.

A first-in-class monoclonal antibody targeting IL-5, it is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels. Though, the mechanism of action for the drug has not been definitively established, said GSK.

Asthma is the most common chronic disease in children in the US, according to data from the American Lung Association. It is estimated that 6 million children in the US are living with asthma, reports the US Center for Disease Control and Prevention (CDC). About 2.5-5% of these cases are characterized as severe​.

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