Duaklir Pressair ([aclidinium + formoterol]; AstraZeneca/Circassia/Kyorin Pharmaceutical) is a twice-daily fixed-dose combination of the long-acting beta 2 agonist formoterol and the long-acting muscarinic antagonist aclidinium. It received EU approval for use in chronic obstructive pulmonary disease (COPD) in November 2014. AstraZeneca lists that it plans to file for US and Japanese regulatory approval of Duaklir Pressair for COPD in 2018.
While Duaklir Pressair demonstrated statistically significant improvements in trough forced expiratory volume in one second compared to its individual components and placebo in its Phase III program in COPD, Datamonitor Healthcare forecasts the drug to have significantly lower uptake compared to the most promising LABA/LAMA combinations, Utibron ([indacaterol + glycopyrrolate]; Sunovion/Novartis/Pfizer/Sosei) and Stiolto Respimat ([olodaterol + tiotropium]; Boehringer Ingelheim). Duaklir Pressair’s anticipated late arrival to the US market will significantly restrict its commercial potential, despite AstraZeneca’s experience in the respiratory market. Duaklir Pressair is forecast to face significant competition from triple-combination therapies, further impacting its market share.
LIST OF FIGURES
11 Figure 1: Duaklir Pressair for COPD – SWOT analysis
12 Figure 2: Datamonitor Healthcare’s drug assessment summary of Duaklir Pressair for COPD
13 Figure 3: Datamonitor Healthcare’s drug assessment summary of Duaklir Pressair for COPD
15 Figure 4: Duaklir Pressair sales for COPD across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES5
le 1: Duaklir Pressair drug profile
7 Table 2: Duaklir Pressair Phase III data in COPD
10 Table 3: Duaklir Pressair Phase III trials in COPD
16 Table 4: Duaklir Pressair sales for COPD across the US, Japan, and five major EU markets, by country ($m), 2017–26
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