Breo Ellipta Approval Expanded to Pediatric Patients With Asthma

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The FDA has expanded the approval of Breo Ellipta to include maintenance treatment of asthma in children 5 to 17 years of age.

The Food and Drug Administration (FDA) has expanded the approval of Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) to include maintenance treatment of asthma in children 5 to 17 years of age. Previously, the product was only approved for maintenance treatment of asthma in adults.

Breo Ellipta is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, and the long-acting beta2-agonist (LABA) vilanterol. The expanded approval was based on data from a 24-week, randomized, double-blind, parallel-group phase 3 trial (ClinicalTrials.gov Identifier: NCT03248128) that included pediatric asthma patients uncontrolled on their current ICS treatment.

Patients aged 12 to 17 years were randomly assigned to receive Breo Ellipta 100/25mcg once daily (n=117) or fluticasone furoate 100mcg once daily (n=112). Participants aged 5 to 11 years were randomly assigned to receive Breo Ellipta 50/25 mcg once daily (n=337) or fluticasone furoate 50mcg once daily (n=336).

The primary endpoint of the study was the weighted mean of forced expiratory volume in 1 second (FEV1) (0 to 4 hours) at week 12. Results showed that among patients 12 to 17 years of age, the difference in least squares (LS) mean change in FEV1 (0 to 4 hours) for Breo Ellipta 100/25mcg compared with fluticasone furoate 100mcg was 106mL (95% CI, -8, 220). In patients 5 to 11 years of age, the difference in LS mean change in FEV1 (0 to 4 hours) for Breo Ellipta 50/25mcg compared with fluticasone furoate 50mcg was 73mL (95% CI, 28-118).

As for safety, adverse reactions reported in at least 3% of pediatric patients treated with Breo Ellipta were nasopharyngitis (10%), upper respiratory tract infection (7%), allergic rhinitis (4%), rhinitis (3%), and headache (3%).

Breo Ellipta is supplied as a disposable light grey and pale blue plastic inhaler containing 2 foil strips, each with 30 blisters. In addition to the 100/25mcg and 200/25mcg dosage strengths, the FDA has approved a new 50mcg/25mcg dosage strength for pediatric patients aged 5 to 11 years.

References:

  1. Food and Drug Administration. FDA Letter: NDA 204275/S-022. Supplement approval: fulfillment of postmarketing requirement. US Food and Drug Administration. May 12, 2023. Accessed May 17, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204275Orig1s022ltr.pdf.
  2. Breo Ellipta. Package insert. GlaxoSmithKline; 2023. Accessed May 17, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204275s022lbl.pdf.