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Breo Ellipta Gets FDA Nod for Treatment of Adults With Asthma
The FDA has expanded the label for Breo Ellipta (fluticasone furoate/vilanterol [FF/VI], GlaxoSmithKline/Theravance, Inc.) to include the once-daily treatment of asthma in patients 18 years of age and older.
Breo Ellipta (FF/VI 100/25 mcg) was originally licensed in May 2013 as a prescription medication for the long-term, once-daily maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. A supplemental new drug application (sNDA) in asthma was submitted to the FDA in June 2014. Breo Ellipta is not indicated for the relief of acute bronchospasm.
The product is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist (LABA) vilanterol. Two strengths, 100/25 mcg and 200/25 mcg, have been approved for use in patients with asthma, administered once-daily using the Ellipta dry-powder inhaler.
The FDA issued a complete response letter related to the proposed use of Breo Ellipta in patients aged 12 to 17 years stating that the data submitted did not show an adequate risk–benefit ratio to support approval in these patients. The agency stated that additional data would be required to further demonstrate the medication’s safety and efficacy in this population.
Breo Ellipta was studied in a clinical trial program involving more than 12,000 subjects 12 years of age and older.
LABAs, such as vilanterol, increase the risk of asthma-related death. Moreover, data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, physicians should prescribe Breo Ellipta only for patients not adequately controlled on a long-term asthma-control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants the initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, the patient should be assessed at regular intervals; step-down therapy (e.g., discontinue Breo Ellipta) should be initiated if possible without loss of asthma control; and the patient should be maintained on a long-term asthma control medication, such as an inhaled corticosteroid. Clinicians should not use Breo Ellipta in patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
Approximately 19 million adults in the U.S. have asthma. Despite medical advances, more than half of these patients continue to experience poor control and significant symptoms. The causes of asthma are not completely understood but are likely to involve an interaction between a person’s genetic make-up and the environment. Key environmental risk factors for the development of asthma include allergens, respiratory infections, and airway irritants.
Sources: GlaxoSmithKline; April 30, 2015; and Breo Ellipta Prescribing Information; April 2015.