Farxiga
Author: Peter Chang
Publisher: Datamonitor Healthcare
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Drug Overview
Farxiga (dapagliflozin; AstraZeneca/Ono Pharmaceutical) is a member of the novel sodium-glucose cotransporter-2 (SGLT-2) inhibitor class. It is approved for the treatment of type 2 diabetes and currently in Phase III trials for the treatment of type 1 diabetes, as well as for chronic kidney disease including diabetic nephropathy. SGLT-2 inhibitors do not target insulin secretion or sensitivity and do not interfere with glucose metabolism. They prevent filtered glucose from being reabsorbed in the kidney rather than actively facilitating glucose filtration and excretion. Due to this distinct mechanism of action, when SGLT-2 inhibitors are used as monotherapy, they do not lower glucose to unsafe levels and thus avoid the risk of hypoglycemia.
Analyst Outlook
Farxiga (dapagliflozin; AstraZeneca/Ono Pharmaceutical) showed a sizable benefit on a renal composite outcome in its cardiovascular outcomes trial (CVOT) in type 2 diabetes, as have other sodium-glucose cotransporter-2 (SGLT-2) inhibitors, bolstering confidence that its chronic kidney disease (CKD) trial will be positive, though it is unclear whether the effects will be as strong in non-diabetics in the study. Likewise, as with competitors, positive results in heart failure hospitalization (HFH) bolster confidence in its pivotal trial in HF, an important co-morbidity. HFH was part of one primary outcome for the DECLARE-TIMI 58 CVOT, along with CV death, so the company is seeking a label expansion even prior to its HF pivotal trial results, though it is uncertain whether this will be achieved.
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Farxiga : Diabetic nephropathy
17 Farxiga : Diabetes type 1
25 Farxiga : Chronic heart failure (CHF)
34 Farxiga : Diabetes type 2
LIST OF FIGURES
12 Figure 1: Datamonitor Healthcare’s drug assessment summary of Farxiga for diabetic nephropathy
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Farxiga for diabetic nephropathy
15 Figure 3: Farxiga sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country, 2017–26
20 Figure 4: Farxiga for type 1 diabetes – SWOT analysis
21 Figure 5: Datamonitor Healthcare’s drug assessment of Farxiga in type 1 diabetes
22 Figure 6: Datamonitor Healthcare’s drug assessment of Farxiga in type 1 diabetes
27 Figure 7: Farxiga for chronic heart failure – SWOT analysis
28 Figure 8: Datamonitor Healthcare’s drug assessment summary of Farxiga for chronic heart failure
29 Figure 9: Datamonitor Healthcare’s drug assessment summary of Farxiga for chronic heart failure
31 Figure 10: Farxiga sales for chronic heart failure across the US, Japan, and five major EU markets, by country, 2017–26
44 Figure 11: Farxiga for type 2 diabetes – SWOT analysis
45 Figure 12: Datamonitor Healthcare drug assessment of Farxiga
46 Figure 13: Datamonitor Healthcare drug assessment scorecard for Farxiga compared to Januvia
48 Figure 14: Farxiga sales for type 2 diabetes across the US, Japan, and five major EU markets, by country, 2016–25
50 Figure 15: Xigduo sales for type 2 diabetes across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
7 Table 1: Farxiga drug profile
9 Table 2: Farxiga Phase III trial in chronic kidney disease, including diabetic nephropathy
10 Table 3: Farxiga Phase II/III trial on UACR and glycemic control in diabetic nephropathy
11 Table 4: Farxiga for diabetic nephropathy – SWOT analysis
18 Table 5: Farxiga drug profile
19 Table 6: Farxiga late-phase trials in type 1 diabetes
26 Table 7: Farxiga drug profile
26 Table 8: Farxiga Phase III trials in chronic heart failure
32 Table 9: Farxiga sales for chronic heart failure across the US, Japan, and five major EU markets, by country ($m), 2017–26
34 Table 10: Farxiga franchise products
35 Table 11: Farxiga drug profile
35 Table 12: Xigduo drug profile
37 Table 13: Overview of pivotal trial data for Farxiga in diabetes
43 Table 14: Key planned and ongoing Phase III clinical trials for Farxiga in diabetes
49 Table 15: Farxiga sales for type 2 diabetes across the US, Japan, and five major EU markets, by country ($m), 2016–25
51 Table 16: Xigduo sales for type 2 diabetes across the US, Japan, and five major EU markets, by country ($m), 2016–25
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