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 NF?B, 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.
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 NF?B, 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
OVERVIEWDrug Overview
Product Profiles
Breo Ellipta: Chronic obstructive pulmonary disease (COPD)
Breo Ellipta: Asthma
LIST OF FIGURES
Figure 1: Breo for COPD – SWOT analysis
Figure 2: The authors drug assessment summary of Breo for COPD
Figure 3: The authors drug assessment summary of Breo for COPD
Figure 4: Breo sales for COPD across the US, Japan, and five major EU markets, by country, 2017–26
Figure 5: Breo Ellipta for asthma – SWOT analysis
Figure 6: The authors drug assessment summary of Breo Ellipta in asthma
Figure 7: The authors drug assessment summary of Breo Ellipta in asthma
Figure 8: Breo Ellipta sales for asthma across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
Table 1: Breo drug profile
Table 2: Breo Phase III data in COPD
Table 3: Breo Phase III trials in COPD
Table 4: Breo sales for COPD across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 5: Breo Ellipta drug profile
Table 6: Breo Ellipta pivotal trial data in asthma
Table 7: Breo Ellipta late-phase trial data in asthma
Table 8: Breo Ellipta sales for asthma across the US, Japan, and five major EU markets, by country ($m), 2017–26
