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FDA Panels Say ‘Yes’ to Asthma Drug Breo Ellipta for Adults, But Not for Adolescents

Approval decision expected in April

The outcome of a joint meeting of the FDA’s Pulmonary–Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee has been announced regarding the supplemental new drug application (sNDA) for Breo Ellipta (fluticasone furoate/vilanterol [FF/VI], ) GlaxoSmithKline/Theravance, Inc.) as a once-daily inhaled treatment for asthma in patients 12 years of age and older.

The panels voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The panels also voted that the efficacy data provide substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against).

However, the panels voted against approval for the proposed indication in 12- to 17-year-olds (2 for, 18 against). They felt that the benefit (4 for, 16 against) and the safety (1 for, 19 against) of FF/VI were not adequately demonstrated in this subpopulation.

The committees recommended that a large long-acting beta-agonist (LABA) safety trial with FF/VI should be required in adults (13 yes, 7 no) and in 12- to 17-year-olds (17 yes, 2 no, and 1 no-vote), similar to the ongoing LABA safety trials being conducted as an FDA post-marketing requirement by each of the manufacturers of LABA-containing asthma treatments.

The FDA’s advisory committees provide nonbinding recommendations for consideration by the agency. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected by April 30, 2015.

Breo, a fixed-dose combination of the inhaled corticosteroid FF and the LABA VI, is administered with the Ellipta dry-powder inhaler device. The sNDA for Breo Ellipta in asthma patients was submitted to the FDA in June 2014 for two once-daily dosing regimens, 100/25 mcg and 200/25 mcg.

Asthma is a chronic lung disease that inflames and narrows the airways. Approximately 26 million people in the U.S. have the disease. Despite medical advances, more than half of patients continue to experience poor disease control and significant symptoms.

The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic makeup and the environment. Key environmental risk factors for the development of asthma include allergens, respiratory infections, and airway irritants.

Breo Ellipta (FF/VI 100/25 mcg) was originally licensed by the FDA 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. Breo Ellipta is not currently indicated for the relief of acute bronchospasm or for the treatment of asthma in the U.S.

Source: GlaxoSmithKline; March 19, 2015.


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