Posted by: Pulse Clinical Team12 February 2014
NICE has given a cautious verdict on the first LABA/LAMA inhaler for COPD- due to be launched in the UK within the next few months.
The Ultibro Breezhaler contains the LABA indacaterol and the LAMA glycopyrronium and is the first of around four LABA/LAMA inhalers currently being developed. It will be licensed as a once-daily maintenance bronchodilator treatment to relieve symptoms in adults with COPD when it is launched in the UK by June this year.
NICE has released an evidence summary which concludes: ‘Although some small statistically significant improvements in lung function, dyspnoea, health status and use of rescue medication were seen with indacaterol/glycopyrronium compared with placebo and active comparators, the clinical importance of these differences is unclear and [its] place in therapy is currently difficult to assess.’
The combination inhaler has been shown to significantly reduce the rate of moderate or severe exacerbations compared with glycopyrronium alone in people with severe or very severe COPD. But the European Medicines Agency considered the reduction insufficient to support an indication for reducing exacerbations.