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April 30, 2015

GSK and Theravance receive FDA approval for asthma drug Breo Ellipta

GlaxoSmithKline (GSK) and Theravance have received approval from the US Food and Drug Administration (FDA) for the Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) as the once-daily treatment for asthma patients aged 18 years and older.

Asthma

GlaxoSmithKline (GSK) and Theravance have received approval from the US Food and Drug Administration (FDA) for the Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) as the once-daily treatment for asthma patients aged 18 years and older.

Breo is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol (VI).

GSK global respiratory Franchise senior vice-president and head Darrell Baker said: "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."

"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."

Two strengths of the asthma drug, 100/25mcg and 200/25mcg, have received approval in the US for use in asthma and need to be administered once-daily using the Ellipta dry powder inhaler.

The efficacy and safety of the asthma drug has been assessed in a clinical trial programme, which included around 12,000 subjects in 23 studies of patients aged 12 years and over.

Theravance president and CEO Michael Aguiar 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."

According to GSK, Breo Ellipta is not indicated for the relief of acute bronchospasm and LABA such as vilanterol, one of the active ingredients in Breo Ellipta, increase the risk of asthma-related death.

In May 2013, FDA granted licence to Breo Ellipta (FF/VI 100/25mcg) 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.


Image: Obstruction of the lumen of a bronchiole by mucoid exudate, goblet cell metaplasia, and epithelial basement membrane thickening in a person with asthma. Photo: courtesy of Yale Rosen.

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