Afrezza (inhaled human insulin; Sanofi) is a drug-device combination product consisting of an ultra-rapid-acting human insulin for oral inhalation, approved for use in the US for the treatment of type 1 and type 2 diabetes. Afrezza utilizes a dry powder formulation of insulin which is delivered in four- or eight-unit cartridges (containing 0.35mg and 0.7mg of insulin respectively) and reaches peak concentration in 12–14 minutes. This is administered using MannKind’s proprietary Dreamboat inhaler. Afrezza is required to be administered immediately before a meal.
Afrezza was developed by MannKind and was initially marketed in partnership with Sanofi. However, in January 2016, MannKind announced that Sanofi had terminated its agreement for the collaborative marketing and development of Afrezza. All commercialization and development activities have been returned to MannKind as of April 2016.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Afrezza : Diabetes type 2
10 Afrezza : Diabetes type 1
LIST OF FIGURES
7 Figure 1: Afrezza for type 2 diabetes – SWOT analysis
8 Figure 2: Datamonitor Healthcare drug assessment of Afrezza
9 Figure 3: Datamonitor Healthcare drug assessment scorecard for Afrezza compared to Lantus
14 Figure 4: Afrezza for type 1 diabetes – SWOT analysis
15 Figure 5: Datamonitor Healthcare’s drug assessment of Afrezza for type 1 diabetes
16 Figure 6: Datamonitor Healthcare’s drug assessment of Afrezza for type 1 diabetes
LIST OF TABLES 5 Table 1: Afrezza drug profile
6 Table 2: Pivotal Afrezza Phase III trials
11 Table 3: Afrezza drug profile
13 Table 4: Afrezza pivotal trial data in type 1 diabetes
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