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AstraZeneca’s COPD drug Duaklir meets primary endpoints in phase III Amplify trial

PBR Staff Writer Published 08 September 2017

AstraZeneca’s Duaklir (aclidinium bromide/formoterol 400µg/12µg twice-daily) has met its primary endpoints in the Phase III Amplify trial of patients with chronic obstructive pulmonary disease (COPD).

The drug showed a statistically-significant improvement in lung function in patients with moderate to very severe stable COPD compared against individual component that included either aclidinium bromide or formoterol.

Duaklir is an approved fixed-dose LAMA/LABA combination of two long-acting bronchodilators, including aclidinium bromide and formoterol fumarate.

Aclidinium bromide is a long-acting muscarinic antagonist(LAMA) and formoterol fumarate is a long-acting beta-agonist (LABA).

Additionally, aclidinium bromide reached its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18µg once-daily.

According to the company, a full assessment of the Amplify data is ongoing and further results will be presented at a forthcoming medical meeting.

Based on the Amplify data, AstraZeneca is planning to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) during the first half of 2018.

Amplify is a 24-week treatment, multicentre, randomised, double-blind, double dummy and parallel-group trial, which is evaluating the efficacy and safety of aclidinium bromide/formoterol 400µg/12µg twice-daily compared to its component parts(aclidinium bromide 400µg twice-daily or formoterol fumarate 12µg twice-daily) and once-daily tiotropium 18µg in moderate to very severe stable COPD patients.

In April this year, AstraZeneca announced a strategic collaboration with Circassia Pharmaceuticals to develop and commercialise Tudorza and Duaklir in the US.

In November 2014, the fixed-dose combination secured approval from the European Medicines Agency (EMA) as maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.

The trial lead investigator Dr. Sanjay Sethi said: “These results demonstrate the improvement in lung function achieved by the combination of aclidinium and formoterol compared to single LAMA bronchodilators tiotropium and aclidinium, with comparable safety.”

AstraZeneca respiratory global medicine leader Steve Lewington said: “The Amplify study top-line results provide further clinical evidence of Duaklir's efficacy and support making this LAMA/LABA combination treatment option available to COPD patients in the US.”

Image: AstraZeneca’s Duaklir has achieved primary endpoints primary endpoints in the Phase III Amplify trial of patients with COPD. Photo: courtesy of AstraZeneca.