Novartis, under license from Vectura and Sosei, developed Seebri Neohaler, a once-daily inhaled formulation of glycopyrrolate. The once-daily long-acting muscarinic antagonist (LAMA) received EU and Japanese approvals for use in chronic obstructive pulmonary disease (COPD) in September 2012, and US approval in October 2015.
Physician and patient familiarity with the gold-standard LAMA Spiriva (tiotropium; Boehringer Ingelheim) has restricted Seebri Neohaler’s uptake. Its late arrival to the US COPD market (in Q1 2016) and the increasing availability of fixed-dose long-acting beta 2 agonist (LABA)/LAMA combination therapies will further impact the drug’s commercial potential. Datamonitor Healthcare believes that glycopyrrolate’s real potential comes from its inclusion in Novartis’s fixed-dose LABA/LAMA combination Utibron ([indacaterol + glycopyrrolate]), which has been approved in all major markets for use in COPD.
LIST OF FIGURES
10 Figure 1: Seebri for COPD – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Seebri Neohaler for COPD
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of Seebri Neohaler for COPD
14 Figure 4: Seebri Neohaler sales for COPD across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
5 Table 1: Seebri Neohaler drug profile
7 Table 2: Seebri Neohaler Phase III data in COPD
9 Table 3: Seebri Neohaler US Phase III trial data
15 Table 4: Seebri Neohaler sales for COPD across the US, Japan, and five major EU markets, by country ($m), 2017–26
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