FDA approves Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) for Asthma in adults-Glaxo Smith Kline
The FDA has approved Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]), from Glaxo Smith Kline, 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. The efficacy and safety of Breo Ellipta was studied in a clinical trial programme involving over 12,000 subjects in 23 studies of patients aged 12 and over.
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.
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