GlaxoSmithKline (GSK) and Theravance, Inc, have announced that Breo Ellipta has been approved by the Food and Drug Administration (FDA) for the once-daily treatment of asthma in patients ages 18 years and older. The efficacy and safety of Breo Ellipta was studied in a clinical trial program involving over 12,000 subjects in 23 studies of patients aged 12 and over. Breo is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol (VI).
Two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler, according to a GSK-Theravance news release.
The FDA issued a complete response letter to the proposed use of Breo Ellipta in patients ages to 12 to 17 years, stating that the data submitted do not show adequate risk-benefit to support the approval in these patients. The agency stated that additional data would be required to further demonstrate the efficacy and safety in this population.
The GSK-Theravance news release notes that Breo Ellipta is also not indicated for the relief of acute bronchospasm.
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, says, “Asthma is a variable condition and guidelines recommend a stepwise approach to treatment with the aim of achieving asthma control.” Baker adds, “Breo Ellipta is our second asthma treatment to be approved in the US in the past year, and now provides physicians with a range of treatment options delivered via the Ellipta inhaler to meet the needs of appropriate adult patients with differing asthma severities.”
Michael W. Aguiar, president and CEO of Theravance, states, “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.”
Source: GSK-Theravance, Inc