Ryzodeg is a fixed-ratio combination of basal insulin analog Tresiba (insulin degludec) with a bolus of prandial insulin analog NovoLog (insulin aspart). The product received regulatory approval in Japan and the EU in 2013. It was not, however, approved in the US until 2015 due to an initial rejection by the US Food and Drug Administration, which requested a dedicated cardiovascular outcomes trial before approval.
Ryzodeg is considered a combination insulin. The insulin degludec and insulin aspart components each retain their own action profile in solution, whereas in premixes, the elements interfere with one another and the short-acting component has a prolonged effect. Ryzodeg comprises a 70:30 ratio of insulin degludec and insulin aspart.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Ryzodeg : Diabetes type 2
12 Ryzodeg : Diabetes type 1
LIST OF FIGURES 8 Figure 2: Datamonitor Healthcare’s drug assessment summary of non-insulin antidiabetic brands for type 2 diabetes
9 Figure 3: Datamonitor Healthcare’s drug assessment summary of insulin brands for type 2 diabetes
15 Figure 6: Sales of SGLT-2 inhibitor brands in type 2 diabetes across the US, Japan, and five major EU markets, by brand, 2016–25
16 Figure 6: DPP-IV inhibitor sales in type 2 diabetes across the US, Japan, and five major EU markets, by brand, 2016–25
17 Figure 7: Sales of Victoza, Trulicity, semaglutide, and biosimilar liraglutide across the US, Japan, and five major EU markets, by drug, 2016–25
LIST OF TABLES 5 Table 1: Ryzodeg drug profile
6 Table 2: Overview of pivotal published trial data for Ryzodeg in type 2 diabetes
13 Table 3: Ryzodeg drug profile
14 Table 4: Ryzodeg pivotal trial data in type 1 diabetes
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