- Filings based on two Phase 3 trials
demonstrating significant clinical remission versus placebo and
safety profile consistent with previous studies
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and
Drug Administration (FDA) has accepted for review a New Drug
Application (NDA) for etrasimod for individuals living with
moderately-to-severely active ulcerative colitis (UC). The FDA’s
decision is expected in the second half of 2023. The European
Medicines Agency (EMA) has also accepted the Marketing
Authorization Application (MAA) for etrasimod in the same patient
population with the decision anticipated in the first half of
2024.
Etrasimod is an oral, once daily, selective
sphingosine-1-phosphate (S1P) receptor modulator designed for
optimized pharmacology and engagement of S1P receptors 1, 4, and 5.
In addition to UC, it is being investigated for a range of other
immuno-inflammatory diseases.
UC is a chronic and often debilitating condition1 that affects
an estimated 3.8 million people in North America and Europe.2
Symptoms of UC can include chronic diarrhea with blood and mucus,
abdominal pain, and urgency.3,4 UC can have a significant effect on
work, family, and social activities. There is a need for additional
advanced therapeutic options in UC that are oral, effective, and
have a favorable risk-benefit profile.
“Ulcerative colitis can substantially impact the day-to-day
lives of people living with this chronic and often debilitating
disease, and many patients never achieve nor maintain remission on
today’s therapies,” said Michael Corbo, PhD, Chief Development
Officer, Inflammation & Immunology, Pfizer Global Product
Development. “We believe that etrasimod, if approved, has the
potential to be a best-in-class, first-line advanced therapy for
people living with moderately-to-severely active ulcerative
colitis, based on its clinical profile.”
These submissions were based on previously announced results
from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52
and ELEVATE UC 12) that evaluated the safety and efficacy of
etrasimod 2 mg once daily on clinical remission in UC patients who
had previously failed or were intolerant to at least one
conventional, biologic, or Janus kinase (JAK) inhibitor therapy.
Both randomized, double-blind, placebo-controlled studies achieved
all primary and key secondary endpoints, with a safety profile
consistent with previous studies.
About ELEVATE UC 52 and ELEVATE UC 12 ELEVATE UC 52 and
ELEVATE UC 12 are pivotal trials that are part of the ELEVATE UC
Phase 3 registrational program.5
ELEVATE UC 52 is a randomized, double-blind, placebo-controlled
trial that utilized a treat-through design comprising of a 12-week
induction period followed by a 40-week maintenance period.
Beginning at week 12, all patients could continue their randomized
treatment; patients whose disease had not improved or had worsened
compared to baseline could discontinue and, if eligible, enroll in
an open-label extension study. The primary objective of this trial
was to assess the safety and efficacy of etrasimod 2 mg once daily
on clinical remission after both 12 and 52 weeks. The primary
endpoint is based on the 3-domain, modified Mayo score (MMS). In
ELEVATE UC 52, clinical remission was 27.0% for patients receiving
etrasimod compared to 7.4% for patients receiving placebo at week
12 (19.8% differential, P≤.001) and was 32.1% compared to 6.7% at
week 52 (25.4% differential, P≤.001). Statistically significant
improvements were attained in all key secondary endpoints,
including endoscopic improvement, symptomatic remission, and
mucosal healing at weeks 12 and 52, and corticosteroid-free
remission and sustained clinical remission at week 52.
ELEVATE UC 12 is a randomized, double-blind, placebo-controlled
trial to assess the efficacy and safety of etrasimod 2 mg
once-daily in subjects with moderately-to-severely active UC. The
primary objective of this trial was to assess the safety and
efficacy of etrasimod on clinical remission at 12 weeks assessed by
the FDA-required, 3-domain, MMS. In ELEVATE UC 12, clinical
remission was achieved among 24.8% of patients receiving etrasimod
compared to 15.2% of patients receiving placebo (9.7% differential,
P=.0264). All key secondary endpoints were met at week 12,
including endoscopic improvement, symptomatic remission, and
mucosal healing.
In ELEVATE UC 12, a similar proportion of patients experienced
treatment-emergent adverse events (AEs) between etrasimod 2 mg and
placebo treatment groups, while in ELEVATE UC 52, it was higher in
the etrasimod 2 mg group compared to placebo. The proportion of
patients experiencing serious AEs was similar between treatment
groups in both trials. The most common treatment-emergent AEs in 3%
or more of etrasimod-treated patients and greater than placebo up
to week 52 in either trial were headache, worsening of UC, COVID-19
infection, dizziness, pyrexia, arthralgia, abdominal pain and
nausea. There were no reports of bradycardia or atrioventricular
block as serious AEs. Data support initiation of etrasimod
treatment does not require complex up-titration regimen.
Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC
12, respectively, were naïve to biologic or JAK inhibitor
therapy.
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Disclosure Notice The information contained in this release is
as of December 21, 2022. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information about
etrasimod, including its potential benefits, best in class
potential and an NDA filed with the FDA and an MAA filed with the
EMA for etrasimod for individuals living with
moderately-to-severely active ulcerative colitis, that involves
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical endpoints, commencement
and/or completion dates for our clinical trials, regulatory
submission dates, regulatory approval dates and/or launch dates, as
well as the possibility of unfavorable new clinical data and
further analyses of existing clinical data; the risk that clinical
trial data are subject to differing interpretations and assessments
by regulatory authorities; whether regulatory authorities will be
satisfied with the design of and results from our clinical studies;
whether and when drug applications may be filed in particular
jurisdictions for etrasimod; whether and when the applications
filed with the FDA and EMA and any such other applications may be
approved by regulatory authorities, which will depend on myriad
factors, including making a determination as to whether the
product's benefits outweigh its known risks and determination of
the product's efficacy and, if approved, whether etrasimod will be
commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of etrasimod; the impact of COVID-19 on Pfizer’s business,
operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2021 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
1 Crohn’s and Colitis Foundation. What is Ulcerative Colitis?
Available at:
https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis.
Accessed December 16, 2022. 2 Seyedian, SS. A review of the
diagnosis, prevention, and treatment methods of inflammatory bowel
disease. J Med Life. 2019;12(2):113-122. 3 Hanauer SB. Inflammatory
bowel disease. N Engl J Med. 1996;334(13):841-8. 4 Irvine EJ.
Quality of Life of Patients with Ulcerative Colitis: Past, Present,
and Future. Inflammatory Bowel Diseases. 2008;14(4):554-563. 5
Sandborn WJ, et al. Etrasimod 2mg once daily as treatment for
moderately to severely active ulcerative colitis: results from the
phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials, presented at DDW
2022; Abstract 968a.
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