NEW YORK--(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,
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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
View source version on businesswire.com: http://www.businesswire.com/news/home/20180214005745/en/
Source: Pfizer Inc. Pfizer Inc.