-Filings based on robust abrocitinib
clinical trial data demonstrating significant symptom improvement
versus placebo as well as a consistent safety profile-
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and
Drug Administration (FDA) accepted for filing and granted Priority
Review designation to the company’s New Drug Application (NDA) for
abrocitinib (100mg and 200mg), an investigational oral once-daily
Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to
severe atopic dermatitis (AD) in patients 12 and older. The FDA is
expected to make a decision in April 2021. The European Medicines
Agency (EMA) has also accepted the Marketing Authorization
Application (MAA) for abrocitinib in the same patient population
with a decision anticipated in the second half of 2021.
“Atopic dermatitis is a serious, unpredictable, and often
debilitating condition that can have a significant impact on the
daily lives of patients and their families,” said Michael Corbo,
PhD, Chief Development Officer, Inflammation & Immunology,
Pfizer Global Product Development. “We are grateful to those who
participated in our clinical studies supporting these regulatory
filings and proud that the FDA has granted abrocitinib both
Breakthrough Therapy and Priority Review designations. We are
working diligently with the regulatory authorities to bring
abrocitinib to patients in the U.S. and the EU, where, if approved,
it may provide an effective and convenient new option.”
The filings were based on the results of a robust Phase 3
clinical trial program, across which abrocitinib demonstrated
statistically superior improvements in skin clearance, disease
extent, and severity, as well as rapid improvements (measured as
early as Week 2) in itch versus placebo. Abrocitinib also
demonstrated a consistent safety profile across trials and was
generally well-tolerated. Findings from the following studies in
the abrocitinib JAK1 Atopic Dermatitis Efficacy and Safety (JADE)
global development program were included in the submissions:
- JADE MONO-1 and JADE MONO-2: A pair of studies designed to
evaluate the efficacy and safety of two doses (100mg and 200mg once
daily) of abrocitinib monotherapy compared to placebo.
- JADE COMPARE: Designed to evaluate the efficacy and safety of
two doses (100mg and 200mg once daily) of abrocitinib compared to
placebo in patients on background topical therapy. The study also
included an active control arm, dupilumab, a biologic treatment
administered by subcutaneous injection, compared with placebo.
“Many patients with moderate to severe atopic dermatitis have
poorly controlled disease. They need additional treatment options
that alleviate the symptoms most important to them,” said Jonathan
Silverberg, MD, PhD, MPH, Department of Dermatology, The George
Washington University School of Medicine and Health Sciences.
“Abrocitinib has demonstrated strong efficacy at relieving the
signs and symptoms of atopic dermatitis, including rapid reduction
of itch, across multiple clinical trials. If abrocitinib is
approved, it could make a meaningful difference in real-world
clinical practice.”
Priority Review designation is granted to medicines that the FDA
considers to have the potential to provide significant improvements
in the safety and effectiveness of the treatment, prevention or
diagnosis of a serious condition. Abrocitinib received Breakthrough
Therapy designation from the FDA for the treatment of patients with
moderate to severe AD in February 2018. Abrocitinib also received a
Promising Innovative Medicine (PIM) designation from the UK’s
Medicines and Healthcare Products Regulatory Agency (MHRA) earlier
this year, which indicates that a product may be eligible for the
early access to medicines scheme (EAMS) based on early clinical
data. EAMS aims to give patients with life threatening or seriously
debilitating conditions access to medicines that do not yet have a
marketing authorization when there is a clear unmet medical
need.
Pfizer recently announced results from the fourth trial in the
JADE global development program, JADE TEEN. Additional data from
other studies in the JADE program will be presented and published
in the coming months.
About Abrocitinib
Abrocitinib is an oral small molecule that selectively inhibits
Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate
multiple cytokines involved in pathophysiology of atopic
dermatitis, including interleukin (IL)-4, IL-13, IL-31, IL-22, and
thymic stromal lymphopoietin (TSLP).
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of
the skin and skin barrier defects.1,2 Lesions of AD are
characterized by erythema (skin turning red or purple depending on
normal skin color), itching, induration (hardening)/papulation
(formulation of papules), and oozing/crusting.2,3
AD is one of the most common, chronic, relapsing childhood
dermatoses, affecting up to 10% of adults and up to 20% of children
worldwide.3,4
About Pfizer’s Immunokinase Inhibitor Leadership
The JAK pathways are believed to play an important role in
inflammatory processes as they are involved in signaling for over
50 cytokines and growth factors, many of which drive
immune-mediated conditions.5 JAK inhibition may offer patients with
these conditions a potential new advanced treatment option.6
Pfizer’s leading JAK biology and chemistry expertise, combined
with our research experience, has uniquely enabled the company to
take a different R&D approach to that of other companies
involved in JAK research, resulting in one of the broadest
immunokinase inhibitor pipelines. Instead of studying a single
molecule for all its potential uses, where it may not be optimal
for some, Pfizer’s candidates with unique selectivity profiles are
purposefully matched to the conditions where we believe they have
the greatest potential to, if approved, address unmet need. Pfizer
has five unique immunokinase inhibitors in late-stage clinical
trials for the potential treatment of ten immune-mediated
diseases:
- Abrocitinib: A JAK1 inhibitor currently under regulatory review
by the FDA and EMA for the potential treatment of
moderate-to-severe AD among adolescents and adults
- Ritlecitinib (PF-06651600): An oral, JAK3/TEC family kinase
inhibitor in a phase 3 clinical trial for the potential treatment
of alopecia areata (AA) and in phase 2 for vitiligo, Crohn’s
disease (CD), and ulcerative colitis (UC)
- Brepocitinib (PF-06700841): A tyrosine kinase 2(TYK2)/JAK1
inhibitor in phase 2 clinical trials for the potential treatment of
psoriasis and AD in topical formulation, and, in oral formulation
for psoriatic arthritis, CD, UC, vitiligo, systemic lupus
erythematosus (SLE), AA and hidradenitis suppurativa (HS)
- PF-06826647: A TYK2 inhibitor under investigation in phase 2
clinical trials for the potential treatment of psoriasis and
HS
- PF-06650833: An IL-1 receptor associated kinase 4 (IRAK4)
inhibitor under investigation for the potential treatment of
rheumatoid arthritis and HS in phase 2 clinical trials
Pfizer Inc.: Breakthroughs that Change Patients’
Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 150 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.pfizer.com. In addition, to
learn more, please visit us on www.pfizer.com and follow us on
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on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this
release is as of October 27, 2020. 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 a
product candidate, abrocitinib, regulatory filings with the FDA and
EMA for abrocitinib, and Pfizer’s ongoing investigational programs
in kinase inhibitor therapies, including their potential benefits,
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 any other jurisdictions for any
potential indication for abrocitinib or in any jurisdictions for
any other investigational kinase inhibitor therapies; whether and
when the applications for abrocitinib pending with the FDA and EMA
may be approved and whether and when 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 abrocitinib or any
such other investigational kinase inhibitor therapies 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 abrocitinib or any other investigational kinase inhibitor
therapies; the impact of COVID-19 on our 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, 2019 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 Hanifin JM, Reed ML. A population-based survey of eczema in
the United States. Dermatitis. 2007;18(2):82-91. 2 Bieber T. Atopic
dermatitis. Dermatology. 2012;1(3):203-217. 3 Oszukowska M,
Michalak I, Gutfreund K, et al. Role of primary and secondary
prevention in atopic dermatitis. Postep Derm Alergol.
2015:32(6):409-420. 4 Nutten S. Atopic dermatitis: global
epidemiology and risk factors. Ann Nutr Metab. 2015;66(suppl
1):8-16. 5 Banerjee, S., Biehl, A., Gadina, M. et al. JAK–STAT
Signaling as a Target for Inflammatory and Autoimmune Diseases:
Current and Future Prospects. Drugs. 2017;77: 521.
https://doi.org/10.1007/s40265-017-0701-9. 6 Telliez JB, Dowty ME,
Wang L, Jussif J, Lin T, Li L, et al. Discovery of a JAK3-selective
inhibitor: functional differentiation of JAK3-selective inhibition
over pan-JAK or JAK1-selective inhibition. ACS Chem Biol.
2016;11(12):3442–51. doi:10.1021/acschembio.6b00677.
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Media: Steve Danehy 212-733-1538 Steven.Danehy@pfizer.com
Investors: Bryan Dunn 212-733-8917 Bryan.Dunn@pfizer.com
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