Immunology Investor Event
sanofi
Dupixent® - New MOA in CSU with
positive Ph III data in bio-naïve patients
Primary endpoint Study A¹: Mean changes from baselines at week 24
Itch reduction
Itch severity
Placebo + SOC²
35%
reduction
-6.01
weekly score (ISS7)
~2X
Dupixent® + SoC²
63%
reduction
-10.243
Itch & hives reduction
Urticaria activity
weekly score (UAS7)
37%
reduction
-12.00
1. LIBERTY CUPID clinical program, 2. Non-sedating H1-antihistamine, 3. p<0.001
65%
reduction
-20.533
~2X
The use of Dupixent for CSU is investigational and the safety and efficacy has not been evaluated by any Regulatory Authority. The trial demonstrated safety results similar
to the known safety profile of Dupixent in its approved indications. For the 24-week treatment period, the occurrence of treatment emergent adverse events were generally
similar between the DupixentⓇ and placebo groups (50% of DupixentⓇ patients and 59% of placebo patients).
20 Immunology Investor Event
Chronic spontaneous urticaria
(CSU) is a debilitating Type 2
inflammatory disease, defined by
intense itch and hives
DupixentⓇ met primary endpoints in
Ph3 Study A¹ of reducing itch and
urticaria activity
In patients refractory to
omalizumab (Study B¹), DupixentⓇ
did not reach statistical significance
in an interim analysis;
numeric improvements observed
across key endpoints
Ambition to move ahead with filingView entire presentation