FDA approves Breo Ellipta for treatment for asthma in adults

FDA has approved fluticasone furoate/vilanterol (Breo Ellipta, Theravance, Inc.) for the treatment of asthma in adults.

Asthma is a chronic lung disease that causes inflammation and narrowing of the airways. It causes recurring periods of wheezing, chest tightness, shortness of breath, and coughing. Approximately 19 million American adults suffer from asthma currently and despite medical advances, many patients continue to experience poor control and significant symptoms.

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Breo Ellipta is a fixed-dose combination of fluticasone furoate, which is an inhaled corticosteroid (ICS), and vilanterol, which is a long-acting beta 2 agonist (LABA). The fluticasone reduces inflammation while the vilanterol acts to open the airways. Breo Ellipta is administered using the Ellipta dry powder inhaler and comes in 2 strengths, 100/25 μg and 200/25 μg.

Breo Ellipta was originally approved by FDA in May 2013 for the long-term, once daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). With the new approval, Breo Ellipta is now indicated for the once-daily treatment of asthma in patients aged 18 years and older as well. FDA declined to approve the drug for use in younger asthma patients and told the manufacturer additional data would be required to demonstrate safety and efficacy in a younger population.

Related:FDA panels approve Breo Ellipta for asthma in adults, not kids

Breo Ellipta should only be prescribed for patients who are not adequately controlled on a long-term asthma control medication or whose disease severity warrants combination therapy. The drug should not be used for the relief of acute bronchospasm. The most common side effects seen in the trials that studied Breo Ellipta use in asthma included nasopharyngitis, headache, and oropharyngeal pain. 

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