A new treatment option will soon be available for children aged five and over with asthma following the US Food and Drug Administration’s (FDA) decision to expand its approval of the GlaxoSmithKline (GSK) Arnuity Ellipta (fluticasone furoate) inhaler.
The medication was first approved in August 2014 as a maintenance treatment for asthma in patients aged 12 and older, but the FDA has expanded this to include children over the age of five. Approval is for use of the inhaled corticosteroid as a maintenance treatment of asthma as a prophylactic therapy in children between five and 11 years of age when delivered as a 50mcg once-daily inhaled dose.
The application to expand the approval of the medication included data from a pivotal study assessing the safety and efficacy of the drug and comparing its effects with those of a placebo. The trial involved 593 children between five and 11 years who suffered from asthma and the results demonstrated “statistically significant” improvements in peak expiratory flow in children administered with the Arnuity Ellipta.
“Despite the challenges of running clinical studies in this age group, we felt it was important to conduct a study to confirm the benefit of Arnuity in improving lung function in younger children with asthma - giving doctors confidence when choosing to prescribe this treatment for children as young as five years old,” said Hal Barron, MD, chief scientific officer and president of research & development at GSK.
Asthma is a disease affecting the lungs and respiratory system and it is characterized by wheezing, tightness in the chest, coughing at night or early in the morning, and breathlessness. Research by the Centers for Disease Control and Prevention (CDC) shows that as many as 32 million people in the United States have been diagnosed with asthma at some point in their lives.
The condition may be exacerbated by triggers, such as air pollution, allergens, tobacco smoke, stress, exercise, and certain chemicals, which can cause the airways of the lungs to narrow or become blocked, making it difficult to breathe.
Medication is usually used to treat asthma, manage the symptoms, and to prevent asthma attacks. A variety of different inhalers are available, including beta-agonist inhalers, such as Ventolin Hfa (albuterol), and inhaled corticosteroids, for example, Pulmicort (budesonide).
In February 2018, the CDC published a Vital Signs report indicating that asthma management in children has improved in recent years, with a smaller percentage of children with the condition requiring hospitalization than in previous years. Between 2001 and 2016, the percentage of children with asthma who experienced one or more asthma attacks in the 122 months leading up to the report declined from 61.7 percent to 53.7 percent.
The CDC’s Asthma Action Plans provides information and advice to assist parents and caregivers in the management of their children’s asthma.
For more information on the Arnuity Ellipta, visit: https://www.arnuity.com/