Ultibro
Publisher: Datamonitor Healthcare
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Analyst Outlook
Ultibro’s (indacaterol/glycopyrrolate bromide; Novartis/Pfizer) extensive clinical trial program for
chronic obstructive pulmonary disease (COPD) and its first-in-class status in Japan and select EU
markets boost its overall clinical and commercial attractiveness. Datamonitor Healthcare forecasts
Ultibro alongside Stiolto Respimat (olodaterol/tiotropium; Boehringer Ingelheim) to drive sales in the
long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) class in the foreseeable
future, as both therapies have demonstrated promising efficacy and safety to date.
Drug Overview
Novartis, under license from Vectura and Sosei, developed Ultibro, a once-daily LABA/LAMA
combination product containing indacaterol and glycopyrronium bromide. The company has developed
the components as monotherapies, and indacaterol (Arcapta) was the first product of the franchise to
gain approval. Ultibro 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) (Sosei, 2013a; Sosei, 2013b; Sosei, 2013c). The LABA/LAMA combination
received US approval in October 2015 (Sosei, 2015).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Ultibro : Chronic obstructive pulmonary disease
LIST OF FIGURES
18 Figure 1: Ultibro for COPD – SWOT analysis
20 Figure 2: Datamonitor Healthcare’s drug assessment summary of Ultibro in COPD
20 Figure 3: Datamonitor Healthcare’s drug assessment summary of Ultibro in COPD
LIST OF TABLES
4 Table 1: Ultibro drug profile
6 Table 2: Phase III IGNITE program for Ultibro
16 Table 3: Phase III trial results for Ultibro
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