Compared to aclidinium bromide or formoterol monotherapies, combination aclidinium bromide/formoterol 400µg/12µg (Duaklir) resulted in a statistically significant and clinically relevant improvement in lung function in moderate to very severe stable COPD, according to results of the phase 3 AMPLIFY study from Almirall.
Duaklir is a twice-daily, fixed-dose LAMA/LABA combination of two long-acting bronchodilators. The therapy is approved in the EU as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Duaklir is not yet approved in the US.
According to results of the AMPLIFY study, Duaklir’s efficacy, safety and tolerability profiles were consistent with current knowledge. In comparison to tiotropium bromide 18µg once-daily, both Duaklir and aclidinium bromide monotherapy demonstrated significantly higher levels of bronchodilation during the night-time, while aclidinium bromide monotherapy showed non-inferior bronchodilation to tiotropium over 24 weeks.
“These results represent a significant milestone for Almirall’s respiratory business transferred to AstraZeneca, as they support the previous regarding of Duaklir and will contribute to making this combination treatment available to COPD patients in the US,” said Eduardo Sanchiz, Almirall CEO.
Based on the positive results of the AMPLIFY study, AstraZeneca is preparing a New Drug Application (NDA) submission to the US FDA for Duaklir (aclidinium bromide/formoterol 400/12mg).