- Breo Ellipta, a fixed-dose combination of fluticasone and vilanterol, is manufactured and distributed by GlaxoSmithKline in partnership with Theravance. The FDA approved the drug for asthma on Thursday.
- The asthma indication only applies to adults, as the FDA issued a Complete Response Letter in which it stated its concerns about use of Breo Ellipta in patients aged 12 to 17.
- The clinical trial program for Breo Ellipta is extensive and includes over 12,000 subjects, who are aged 12 or over.
This is a good moment for GSK/Theravance coming on the heels of having to backtrack to resolve concerns about safety. Previously, there had been concerns about vilanterol-related asthma deaths, forcing Glaxo to extensively test Breo Ellipta, which contains a corticosteroid and vilanterol, and submit the results to the FDA.
The large-scale clinical trial program was enough to convince the FDA that this inhaled corticosteroid and long-acting beta-2 agonist is safe for use in patients with asthma. But there are extensive safety instructions included in the label, with a special note that Breo Ellipta is not indicated for the relief of bronchospasm.
Breo Ellipta is a once-daily medication, which is also indicated for the treatment of chronic obstructive pulmonary disorder (COPD).