FDA Approves BREO® ELLIPTA® To Treat Adults With Asthma In The US

FDA Approves BREO® ELLIPTA® To Treat Adults With Asthma In The US

GlaxoSmithKline and Theravance, Inc. recently announced that the FDA has approved BREO® ELLIPTA® (fluticasone furoate/vilanterol [FF/VI]) as a once-daily treatment of asthma for patients aged 18 and older. However, Breo Ellipta is not approved to address acute bronchospasm.

Breo features a determined dose of inhaled corticosteroid (ICS) fluticasone furoate (FF) in combination with the long-acting beta2-agonist (LABA) vilanterol (VI).Two different doses have been approved in the United States to address asthma, 100/25mcg and 200/25mcg, both administered once per day through the Ellipta dry powder inhaler.

GSK’s representative Darrell Baker said: “Asthma is a variable condition and guidelines recommend a stepwise approach to treatment with the aim of achieving asthma control. 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, CEO and President of Theravance, stated: “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.”

The FDA did not approve the usage of Breo Ellipta in individuals between 12 and 17 years old, saying it does not show adequate risk-benefit and more efficacy and safety data are needed.

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The efficacy and safety of Breo Ellipta was studied in a clinical trial that enrolled more than 12,000 individuals between 12 years of age and older in 23 studies.

The FDA approved Breo Ellipta for the once-daily treatment of asthma in those 18 years and older. LABA, like vilanterol, is one of the active ingredients present in Breo Ellipta and increases the risk of asthma-related death and of asthma-related hospitalization in adolescent and pediatric patients. As a result, physicians should only prescribe Breo Ellipta for those who are 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. When the disease is controlled, it is crucial to discontinue Breo Ellipta and, if possible, without losing the control of asthma through the utilization of inhaled corticosteroids.

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