GSK : FDA Approves BREO ELLIPTA To Treat Adults With Asthma In US

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) and Theravance Inc. (THRX) announced that the US Food and Drug Administration has approved BREO ELLIPTA (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is not indicated for the relief of acute bronchospasm.

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.

The FDA issued a complete response letter related to the proposed use of Breo Ellipta in patients aged 12-17 stating that the data submitted do not show adequate risk-benefit to support the approval in these patients. The FDA stated that additional data would be required to further demonstrate the safety and efficacy in this population.