Breo Ellipta
Author: Chris Mulligan
Publisher: Datamonitor Healthcare
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Drug Overview
Breo Ellipta (GlaxoSmithKline/Innoviva) is a combination of fluticasone furoate and vilanterol indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Fluticasone furoate is an inhaled corticosteroid that activates the glucocorticoid response element and inhibits pro-inflammatory transcription factors such as NFκB, and antigen-induced lung eosinophilia, thereby suppressing inflammation. Vilanterol is a long-acting beta 2 agonist that stimulates intracellular adenylyl cyclase, an enzyme that catalyzes the conversion of adenosine triphosphate to cyclic-3’,5’-adenosine monophosphate (AMP). Increased levels of cyclic AMP result in the relaxation of bronchial smooth muscles and inhibition of the release of mediators of immediate hypersensitivity from mast cells.
Breo received US approval for use in COPD in May 2013 and launched as the first once-daily ICS/LABA in the COPD market in October 2013. Breo received EU approval for use in COPD in November 2013 (under the brand name Relvar), and became available in the UK and Germany in January 2014. In February 2016, GlaxoSmithKline filed Breo for the treatment of COPD in Japan. It was subsequently approved in December 2016 and launched early 2017.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Breo Ellipta : Chronic obstructive pulmonary disease (COPD)
25 Breo Ellipta : Asthma
LIST OF FIGURES
17 Figure 1: Breo for COPD – SWOT analysis
18 Figure 2: Datamonitor Healthcare’s drug assessment summary of Breo for COPD
19 Figure 3: Datamonitor Healthcare’s drug assessment summary of Breo for COPD
21 Figure 4: Breo sales for COPD across the US, Japan, and five major EU markets, by country, 2017–26
33 Figure 5: Breo Ellipta for asthma – SWOT analysis
34 Figure 6: Datamonitor Healthcare’s drug assessment summary of Breo Ellipta in asthma
35 Figure 7: Datamonitor Healthcare’s drug assessment summary of Breo Ellipta in asthma
37 Figure 8: Breo Ellipta sales for asthma across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: Breo drug profile
7 Table 2: Breo Phase III data in COPD
12 Table 3: Breo Phase III trials in COPD
22 Table 4: Breo sales for COPD across the US, Japan, and five major EU markets, by country ($m), 2017–26
25 Table 5: Breo Ellipta drug profile
27 Table 6: Breo Ellipta pivotal trial data in asthma
30 Table 7: Breo Ellipta late-phase trial data in asthma
38 Table 8: Breo Ellipta sales for asthma across the US, Japan, and five major EU markets, by country ($m), 2017–26
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