Pfizer Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patie...
February 14 2018 - 8:30AM
Business Wire
Pfizer Inc. (NYSE:PFE) today announced its once-daily oral Janus
kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy
designation from the U.S. Food and Drug Administration (FDA) for
the treatment of patients with moderate-to-severe atopic dermatitis
(AD). The Phase 3 program for PF-04965842 initiated in December and
is the first trial in the JAK1
Atopic Dermatitis Efficacy and Safety (JADE) global
development program.
“Achieving Breakthrough Therapy Designation is an important
milestone not only for Pfizer but also for patients living with the
often devastating impact of moderate-to-severe atopic dermatitis,
their providers and caregivers,” said Michael Corbo, Chief
Development Officer, Inflammation & Immunology, Pfizer Global
Product Development. “We look forward to working closely with the
FDA throughout our ongoing Phase 3 development program with the
hope of ultimately bringing this important new treatment option to
these patients.”
Breakthrough Therapy Designation was initiated as part of the
Food and Drug Administration Safety and Innovation Act (FDASIA)
signed in 2012. As defined by the FDA, a breakthrough therapy
is a drug intended to be used alone or in combination with one or
more other drugs to treat a serious or life-threatening disease or
condition and preliminary clinical evidence indicates that the drug
may demonstrate substantial improvement over existing therapies on
one or more clinically significant endpoints, such as substantial
treatment effects observed early in clinical development. If a drug
is designated as a breakthrough therapy, the FDA will expedite the
development and review of such drug.1
About PF-04965842 and Pfizer’s Kinase Inhibitor
Leadership
PF-04965842 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 AD including
interleukin (IL)-4, IL-13, IL-31 and interferon gamma.
Pfizer has established a leading kinase research capability with
multiple unique kinase inhibitor therapies in development. As a
pioneer in JAK science, the Company is advancing several
investigational programs with novel selectivity profiles, which, if
successful, could potentially deliver transformative therapies for
patients. Pfizer has three additional kinase inhibitors in Phase 2
development across multiple indications:
- PF-06651600: A JAK3 inhibitor under
investigation for the treatment of rheumatoid arthritis, ulcerative
colitis and alopecia areata
- PF-06700841: A tyrosine kinase 2
(TYK2)/JAK1 inhibitor under investigation for the treatment of
psoriasis, ulcerative colitis and alopecia areata
- PF-06650833: An interleukin-1
receptor-associated kinase 4 (IRAK4) inhibitor under investigation
for the treatment of rheumatoid arthritis
Working together for a healthier world®
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. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. 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 Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this
release is as of February 14, 2018. 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
PF-04965842 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 trial
commencement and completion dates and regulatory submission dates,
as well as the possibility of unfavorable clinical trial results,
including unfavorable new clinical data and additional analyses of
existing data; risks associated with preliminary data; the risk
that clinical trial data are subject to differing interpretations,
and, even when we view data as sufficient to support the safety
and/or effectiveness of a product candidate, regulatory authorities
may not share our views and may require additional data or may deny
approval altogether; 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
jurisdictions for any potential indication for PF-04965842 or any
other investigational kinase inhibitor therapies; whether and when
any such applications may be approved by regulatory authorities,
which will depend on the assessment by such regulatory authorities
of the benefit-risk profile suggested by the totality of the
efficacy and safety information submitted, and, if approved,
whether PF-04965842 or any such other investigational kinase
inhibitor therapies will be commercially successful; decisions by
regulatory authorities regarding labeling, safety and other matters
that could affect the availability or commercial potential of
PF-04965842 or any other investigational kinase inhibitor
therapies; 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, 2016 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 Food and Drug Administration Fact Sheet Breakthrough Therapies
at
https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm
accessed on January 25, 2018
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version on businesswire.com: http://www.businesswire.com/news/home/20180214005745/en/
Pfizer Inc.Media:Dean Mastrojohn,
212-733-6944Dean.Mastrojohn@pfizer.comorInvestors:Ryan Crowe,
212-733-8160Ryan.crowe@pfizer.com
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