Drug Overview
Novartis, under license from Vectura and Sosei, developed Utibron, a once-daily long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) combination product containing indacaterol and glycopyrrolate. The company has developed the components as monotherapies, and Arcapta (indacaterol) was the first product of the franchise to gain approval. Utibron received EU and Japanese approvals for use in COPD in September 2013, and launched in Germany and Japan in November 2013, ahead of GlaxoSmithKline’s Anoro ([umeclidinium + vilanterol]). The LABA/LAMA combination received US approval in October 2015.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Utibron Neohaler : Chronic obstructive pulmonary disease (COPD)
LIST OF FIGURES
14 Figure 1: Utibron for COPD – SWOT analysis
15 Figure 2: Datamonitor Healthcare’s drug assessment summary of Ultibro/Utibron for COPD
16 Figure 3: Datamonitor Healthcare’s drug assessment summary of Ultibro/Utibron for COPD
18 Figure 4: Utibron sales for COPD across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
5 Table 1: Utibron drug profile
7 Table 2: Utibron Phase III EXPEDITION trial data in COPD
9 Table 3: Utibron other Phase III data in COPD
19 Table 4: Utibron sales for COPD across the US, Japan, and five major EU markets, by country ($m), 2017–26