Drug Overview
Onglyza (saxagliptin; AstraZeneca/Kyowa Hakko Kirin) is a member of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class. DPP-IV is an enzyme responsible for the rapid degradation of the incretin hormone glucagon-like peptide-1 (GLP-1), which is released postprandially from the gut. Inhibition of DPP-IV augments the amount of active GLP-1, which in turn triggers increased insulin secretion from the pancreas in a glucose-dependent manner and suppresses the release of glucagon, resulting in lowered blood glucose levels. The drug was developed as part of a joint venture between AstraZeneca and Bristol-Myers Squibb. However, AstraZeneca has taken full ownership and marketing responsibilities after buying its partner’s share of the venture. Bristol-Myers Squibb initially out-licensed Onglyza to Otsuka for marketing in Japan. Otsuka subsequently transferred these marketing rights to Kyowa Hakko Kirin upon Onglyza’s approval in 2013.
The franchise product Kombiglyze ([saxagliptin + metformin; AstraZeneca]) addresses the fact that Onglyza is generally used as a second- or third-line treatment option as an add-on to metformin.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Onglyza : Diabetes type 2
LIST OF FIGURES
10 Figure 1: Onglyza brand franchise for type 2 diabetes – SWOT analysis
11 Figure 2: Datamonitor Healthcare drug assessment of Onglyza
12 Figure 3: Datamonitor Healthcare drug assessment scorecard for Onglyza compared to Januvia
14 Figure 4: Onglyza sales for type 2 diabetes across the US, Japan, and five major EU markets, by country, 2016–25
16 Figure 5: Kombiglyze sales for type 2 diabetes across the US, Japan, and five major EU markets, by country, 2016–25
18 Figure 6: SaxaDapa sales for type 2 diabetes across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
4 Table 1: Onglyza franchise products
5 Table 2: Onglyza drug profile
5 Table 3: Kombiglyze (XR) drug profile
7 Table 4: Overview of pivotal trial data for Onglyza franchise in diabetes
15 Table 5: Onglyza sales for type 2 diabetes across the US, Japan, and five major EU markets, by country ($m), 2016–25
17 Table 6: Kombiglyze sales for type 2 diabetes across the US, Japan, and five major EU markets, by country ($m), 2016–25
19 Table 7: SaxaDapa sales for type 2 diabetes across the US, Japan, and five major EU markets, by country ($m), 2016–25