TGA green-lights corticosteroid-free option for reducing COPD flare-ups
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COPD patients now have access to a corticosteroid-free option to reduce exacerbations, following the TGA’s approval of a new indication for indacaterol-glycopyrronium (Ultibro Breezhaler 110/50).1
The indication has been expanded to include “the reduction of exacerbations of COPD in patients with a history of exacerbations”, as well as its previous approval for use as a once-daily maintenance bronchodilator treatment to relieve COPD symptoms.1
Ultibro Breezhaler is the only long-acting beta agonist/long-acting muscarinic antagonist (LABA/LAMA) combination approved in Australia as a treatment for reducing all exacerbations of COPD.1
In assessing COPD therapies, the PBAC noted that “there appears to be a high rate of initiation to ICS/LABAs in COPD which is inconsistent with clinical guidelines”.2
Australia’s COPD-X Guidelines now acknowledge that in COPD patients with frequent exacerbations, LAMA/LABA combinations are superior to ICS/LABA combinations in reducing exacerbations with a decreased risk of pneumonia, citing a meta-analysis and the landmark FLAME trial that also supported the change in indication for Ultibro Breezhaler.3–5