Immunology Investor Event
sanofi
Pivotal results support Dupixent'sⓇ potential as
the first and only biologic for Eosinophilic Esophagitis
U.S. regulatory submission completed, pending FDA acceptance
Proportion of patients achieving peak esophageal
eosinophil count ≤ 6 eos/hpf
FDA
Breakthrough
Therapy
Designation
Absolute change from baseline in DSQ score, symptoms
Responders (%)
80
88
100
60
60
40
Part A
P < 0.0001
***
60%
20
5%
6%
0
Placebo
dupilumab
300 mg qw
Placebo
Part B
P < 0.0001
***
59%
dupilumab
300 mg qw
Absolute change from
baseline, LS mean (SE)
Part A
Placebo
dupilumab
300 mg qw
Placebo
0
-15
15212
-5
-10
-9.6
-20
-25
-30
-21.9
I
***
P < 0.001
I
-13.9
Part B
dupilumab
300 mg qw
***
P < 0.0001
-23.8
Sources: Rothenberg Met al., Journal of Allergy and Clinical Immunology, Vol 149, Issue 2, Supplement, 2022, Pg AB312,
The safety results of the trials were generally consistent with the known safety profile of Dupixent in its approved indications. For the 24-week treatment period, overall rates of adverse events were 84% (67/80) for Dupixent 300 mg weekly and 71%
(55/78) for placebo. Dupixent in EoE is investigational and has not been fully reviewed by regulatory authorities; Dupixent is developed and commercialized in collaboration with Regeneron
23 Immunology Investor EventView entire presentation