GlaxoSmithKline, Theravance file for expanded US approval of Breo Ellipta to include asthma

GlaxoSmithKline and Theravance said Monday that the companies applied for expanded FDA approval to market Breo Ellipta (fluticasone furoate/vilanterol) as a treatment for asthma in patients aged 12 years and older. The submission seeks clearance of two once-daily dose regimens administered via the Ellipta dry powder inhaler.

The companies stated that the application was based on a clinical development programme for the therapy that included 23 studies involving a total of 12 051 patients with asthma. Last December, the drugmakers reported positive Phase III results demonstrating that the inhaled corticosteroid and long-acting beta agonist combination product significantly improved lung function in adults with asthma, compared with fluticasone furoate alone.

Breo Ellipta was initially cleared in the US in May 2013 for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), and was later approved in Europe under the name Relvar Ellipta for adults with COPD and for people aged 12 and over whose asthma is inadequately controlled with inhaled corticosteroids and as-needed inhaled short-acting beta agonists. The product is also authorised in Japan under the Relvar Ellipta brand for the treatment of bronchial asthma, although the companies withdrew their Japanese application for the drug in the COPD indication last year.

For related analysis, read ViewPoints: Streamlined and refocused, but GlaxoSmithKline needs respiratory portfolio to deliver, as well as Physician Views Poll Results: Stuttering start for GlaxoSmithKline's Breo extends beyond reimbursement issues...but sentiment remains high for Anoro.

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