COPD Treatment Now Approved for Asthma
The FDA today expanded the indication of fluticasone furoate/vilanterol (Breo Ellipta) for the treatment of asthma.
The FDA today expanded the indication of GlaxoSmithKline and Theravance’s fluticasone furoate/vilanterol (Breo Ellipta), approving it for the once-daily treatment of asthma in patients aged 18 years and older.
A fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate and the long-acting beta2-agonist (LABA) vilanterol, Breo Ellipta was previously approved for the treatment of chronic obstructive pulmonary disease.
The FDA based its nod on the results of a clinical trial program that evaluated the drug’s safety and efficacy for the treatment of asthma in 12,000 patients aged 12 years and older. In March 2015, the agency’s advisory committee recommended the expanded indication for adult patients in a 16-4 vote.
“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,” said Theravance president and CEO Michael W. Aguiar in a press release. “We are pleased by today's approval of Breo Ellipta and look forward to making this important medicine available to the appropriate adult patients among those living with the disease.”
In a response letter regarding the proposed use of Breo Ellipta for the treatment of asthma in patients aged 12 to 17 years, the FDA stated the submitted data did not show adequate risk-benefit to support the approval in these patients. Additionally, the drug is not indicated for the relief of acute bronchospasm.