EC Approves Fluticasone Furoate/Vilanterol for Asthma, COPD

Megan Brooks


November 18, 2013

The European Commission has granted marketing approval for fluticasone furoate/vilanterol (FF/VI) (Relvar Ellipta, GlaxoSmithKline and Theravance) for the treatment of asthma and chronic obstructive pulmonary disease (COPD), the companies announced today in a joint news release.

The approval follows a favorable opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use in September, as reported by Medscape Medical News.

Relvar, which is now licensed across 31 European countries, combines the inhaled corticosteroid FF and the long-acting beta2-agonist VI, delivered in the Ellipta dry powder inhaler.

FF/VI is recommended for routine treatment of asthma in adults and adolescents aged at least 12 years who require a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) because their symptoms are not adequately managed with inhaled corticosteroids and "as-needed" inhaled short-acting beta2-agonist. Two strengths of FF/VI have been approved for asthma: 92/22 and 184/22 μg, given once daily.

FF/VI is also recommended for treatment of symptoms in adults with COPD with a forced expiratory volume in 1 second lower than 70% predicted normal (postbronchodilator) with a history of exacerbation, despite regular bronchodilator therapy. The approved strength in COPD is 92/22 μg once daily.

The approval follows an European Medicines Agency review of 10 clinical studies in 7783 patients with COPD and 16 studies in 9326 patients with asthma, the companies said.

The US Food and Drug Administration approved FF/VI (Breo Ellipta, GlaxoSmithKline and Theravance) 100/25 μg for COPD in May 2013 and Health Canada approved it under the same trade name for COPD in July 2013.

The lower of the 2 strengths recommended in Europe (92/22 μg) is equivalent to the 100/25 μg predispensed inhaler-given dose that is approved in the United States.


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