Regulatory Decision Summary for Breo Ellipta
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
This Supplement to a New Drug Submission (SNDS) for Breo Ellipta 100/25 μg [100 μg fluticasone furoate (FF) and 25 μg vilanterol (VI) as trifenatate] and 200/25 μg (200 μg FF and 25 μg VI as trifenatate) follows the submission and approval of Breo Ellipta 100/25 μg for chronic obstructive pulmonary disease (COPD). This SNDS was filed to obtain marketing authorization for Breo Ellipta 100/25 μg and 200/25 μg for the treatment of asthma.
Breo Ellipta is a fixed-dose combination of FF and VI to be administered by oral inhalation. Neither component is currently marketed as single ingredient product for the treatment of asthma. Fluticasone furoate is an inhaled corticosteroid (ICS), and VI is a long-acting beta2-agonist (LABA). Both FF and VI are on the Prescription Drug List.
Why was the decision issued?
The efficacy of two doses of Breo Ellipta, 100/25 µg and 200/25 µg, for the treatment of asthma was evaluated in four randomized, double-blind, parallel-group clinical trials in adolescent and adult subjects aged 12 years and older with asthma. The efficacy parameters of interest were bronchodilation (in three of the studies) and reduction in asthma exacerbations (in one study).
Based on the efficacy data from the three bronchodilator studies and the exacerbation study, the efficacy of the two doses of Breo Ellipta 100/25 and Breo Ellipta 200/25 in adults, 18 years of age and older, with asthma has been demonstrated. The benefit-risk profile of both doses of Breo Ellipta is also supported by the safety data. Overall, the benefit-risk profile of Breo Ellipta 100/25 and 200/25 for the treatment of asthma in the adult population, 18 years of age and older, is considered positive.
In sub-group analyses, an increased risk for asthma exacerbations and asthma-related hospitalizations were identified for the adolescent population, 12-17 years of age. Based on the numerical differences in efficacy and safety which favour FF alone versus FF/VI, and in view of the overall safety concerns with LABAs in patients with asthma, particularly children and adolescents, Health Canada considers the benefit-risk profile of Breo Ellipta for the treatment of asthma in adolescents as negative.
The approval of Breo Ellipta 100/25 and 200/25 for once-daily maintenance treatment of asthma in patients aged 18 years and older with reversible obstructive airways disease is recommended.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| BREO ELLIPTA | 02444186 | GLAXOSMITHKLINE INC | FLUTICASONE FUROATE 200 MCG / ACT VILANTEROL (VILANTEROL TRIFENATATE) 25 MCG / ACT |