GlaxoSmithKline plc and Theravance, Inc have announced that their drug Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) has been approved by the US Food and Drug Administration (FDA) as a once-daily treatment of asthma in patients aged 18 years and older.
The press release for the announcement notes that Breo is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol (VI). The US FDA has approved two strengths – 100/25mcg and 200/25mcg – for use in asthma and has to be administered once-daily using the Ellipta dry powder inhaler.
This is GSK’s second drug for asthma treatment to be approved by the US FDA in the past year. Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said that with the approval of Breo Ellipta physicians in the US will have a range of treatment options to meet the needs of appropriate adult patients with differing asthma severities.
The efficacy and safety of Breo Ellipta was studied in a clinical trial programme involving over 12,000 subjects in 23 studies of patients aged 12 and over. In its response letter, the FDA explained why it didn’t approve the use of Breo Ellipta in patients aged 12-17 stating that the data submitted do not show adequate risk-benefit to support the approval in these patients.
The FDA stated that additional data would be required to further demonstrate the safety and efficacy in this population.
Following submission of a supplemental new drug application (sNDA) to the FDA, Breo Ellipta has been approved for the once-daily treatment of asthma in patients aged 18 years and older. LABA, such as vilanterol, one of the active ingredients in Breo Ellipta, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalisation in paediatric and adolescent patients. Therefore, when treating patients with asthma, physicians should only prescribe Breo Ellipta for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Breo Ellipta) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Breo Ellipta for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
Breo Ellipta is NOT indicated for the relief of acute bronchospasm.
Michael W. Aguiar, President and Chief Executive Officer of Theravance, Inc., said: “We believe the approval of Breo Ellipta as a once-daily ICS/LABA treatment for adults with asthma is a significant catalyst for Theravance, as asthma affects nearly 19 million adults in the US. We are pleased by today’s approval of Breo Ellipta and look forward to making this important medicine available to the appropriate adult patients among those living with the disease.”
