Dermira Receives Fast Track Designation from FDA for Lebrikizumab for the Treatment of Atopic Dermatitis
December 10 2019 - 8:30AM
Business Wire
Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company
dedicated to bringing biotech ingenuity to medical dermatology by
delivering differentiated, new therapies to the millions of
patients living with chronic skin conditions, today announced that
the
U.S. Food and Drug Administration (FDA) has granted Fast Track
designation for lebrikizumab, its novel, investigational treatment
being evaluated for patients with moderate-to-severe atopic
dermatitis.
Fast Track is a designation granted by the FDA intended to
facilitate the drug development process and expedite the review of
therapies to treat serious conditions and fill an unmet medical
need, including by demonstrating an advantage over currently
available therapy. The goal of the Fast Track process is to ensure
important new treatments reach patients as quickly as possible.
“We are pleased that the FDA granted lebrikizumab its Fast Track
designation and recognizes the unmet need for patients living with
moderate-to severe atopic dermatitis and the potential for
lebrikizumab to offer a treatment for this serious condition,” said
Tom Wiggans, chairman and chief executive officer of Dermira. “This
Fast Track designation puts us one step closer to potentially
delivering a new therapeutic option more quickly to patients should
the results from earlier Phase 2 studies be confirmed in the
ongoing Phase 3 studies assessing the safety, efficacy and
tolerability of the investigational therapy.”
Lebrikizumab is currently being evaluated in two Phase 3
studies, ADvocate 1 and ADvocate 2, to confirm its safety and
efficacy in adolescent and adult patients, ages 12 years and older,
with moderate-to-severe atopic dermatitis.
About Atopic Dermatitis
Atopic dermatitis is the most common and severe form of eczema,
a chronic inflammatory condition that can present as early as
childhood and continue into adulthood. A moderate-to-severe form of
the disease is characterized by a range of signs and symptoms,
including rashes on the skin that often cover much of the body, as
well as intense, persistent itching. The condition can have a
negative impact on patients’ mental and physical functioning,
limiting their daily activities and health-related quality of life.
Patients with moderate-to-severe atopic dermatitis have reported a
larger impact on quality of life than patients with psoriasis.
About Lebrikizumab
Lebrikizumab is a novel, investigational, monoclonal antibody
designed to bind IL-13 with very high affinity, specifically
preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex
and subsequent signaling, thereby inhibiting the biological effects
of IL-13 in a targeted and efficient fashion. IL-13 is believed to
be a central pathogenic mediator that drives multiple aspects of
the pathophysiology underlying the range of signs and symptoms of
atopic dermatitis by promoting type 2 inflammation and mediating
its effects on tissue, resulting in skin barrier dysfunction, itch,
skin thickening and infection.
About Dermira
Dermira is a biopharmaceutical company dedicated to bringing
biotech ingenuity to medical dermatology by delivering
differentiated, new therapies to the millions of patients living
with chronic skin conditions. Dermira is committed to understanding
the needs of both patients and physicians and using its insight to
identify, develop and commercialize leading-edge medical
dermatology products. The company’s approved treatment, QBREXZA®
(glycopyrronium) cloth, is indicated for pediatric and adult
patients (ages 9 and older) with primary axillary hyperhidrosis
(excessive underarm sweating). Please see the QBREXZA prescribing
information. Dermira is currently evaluating lebrikizumab in a
Phase 3 clinical development program for the treatment of
moderate-to-severe atopic dermatitis (a severe form of eczema) and
also has early-stage research and development programs in other
areas of dermatology. Dermira is headquartered in Menlo Park,
Calif. For more information, please visit http://www.dermira.com.
Follow Dermira on Twitter, LinkedIn and Instagram.
In addition to filings with the Securities and Exchange
Commission (SEC), press releases, public conference calls and
webcasts, Dermira uses its website (www.dermira.com), LinkedIn page
(https://www.linkedin.com/company/dermira-inc-), corporate
Instagram account (https://www.instagram.com/dermira_inc/) and
corporate Twitter account (@DermiraInc) as channels of distribution
of information about its company, product candidates, planned
financial and other announcements, attendance at upcoming investor
and industry conferences and other matters. Such information may be
deemed material information and Dermira may use these channels to
comply with its disclosure obligations under Regulation FD.
Therefore, investors should monitor Dermira’s website, LinkedIn
page, Instagram and Twitter accounts in addition to following its
SEC filings, news releases, public conference calls and
webcasts.
Forward-Looking Statements
The information in this news release contains forward-looking
statements and information within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, which are subject to
the “safe harbor” created by those sections. This news release
contains forward-looking statements that involve substantial risks
and uncertainties, including statements with respect to Dermira’s
goal of bringing biotech ingenuity to medical dermatology by
delivering differentiated, new therapies to the millions of
patients living with chronic skin conditions; the potential for
lebrikizumab to offer a treatment for patients living with
moderate-to severe atopic dermatitis; and Dermira’s ability to
deliver a new therapeutic option more quickly to patients with
moderate-to severe atopic dermatitis should the results in the
ongoing Phase 3 studies confirm the results from the earlier Phase
2 studies. These statements deal with future events and involve
known and unknown risks, uncertainties and other factors that may
cause actual results, performance or achievements to be materially
different from the information expressed or implied by these
forward-looking statements. Factors that could cause actual results
to differ materially include risks and uncertainties such as those
relating to the design, implementation and outcomes of Dermira’s
Phase 3 clinical trials evaluating lebrikizumab in adult and
adolescent patients with moderate-to-severe atopic dermatitis; the
impact of competitive clinical trials, products and therapies;
Dermira’s dependence on third-party clinical research
organizations, manufacturers, suppliers and distributors; the
outcomes of future meetings with regulatory agencies; Dermira’s
ability to obtain necessary additional capital; market acceptance
of Dermira’s current and potential products; Dermira’s ability to
attract and retain key employees; Dermira’s ability to manage the
growth and complexity of its organization; Dermira’s ability to
maintain, protect and enhance its intellectual property; and
Dermira’s ability to continue to stay in compliance with its
material contractual obligations, applicable laws and regulations.
You should refer to the section entitled “Risk Factors” set forth
in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly
Reports on Form 10-Q and other filings Dermira makes with the SEC
from time to time for a discussion of important factors that may
cause actual results to differ materially from those expressed or
implied by Dermira’s forward-looking statements. Furthermore, such
forward-looking statements speak only as of the date of this news
release. Dermira undertakes no obligation to publicly update any
forward-looking statements or reasons why actual results might
differ, whether as a result of new information, future events or
otherwise, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20191210005383/en/
Media: Erica Jefferson Vice President, Corporate Communications
650-421-7216 media@dermira.com
Erin Murphy Director, Corporate Communications 650-422-7746
erin.murphy@dermira.com Investors: Andrew Guggenhime Chief
Financial Officer 650-421-7200 investor@dermira.com
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