- DAXXIFY® (daxibotulinumtoxinA-lanm) for Injection named to
TIME’s list of the best inventions of 2023.
- DAXXIFY® is a long-lasting peptide enhanced neuromodulator
that delivers the first true innovation in neuromodulator
formulation in more than 30 years.
TIME® has unveiled its annual Best Inventions list, which
features 200 of the year’s best innovations that are making the
world better, smarter, and more enjoyable.
For 2023, TIME® solicited nominations from their editors and
correspondents around the world, and through an application
process, paying special attention to growing fields – such as AI,
green energy, and sustainability. The entrants were then evaluated
against a number of key factors, including originality, efficacy,
ambition, and impact.
Of the new list, TIME’s editors write: “The result is a list of
200 groundbreaking inventions (and 50 special mention inventions) —
including the world's most powerful supercomputer, a game-changing
entertainment venue, and a new shape — that are changing how we
live, work, play, and think about what’s possible.”
DAXXIFY® - The First True Innovation in Neuromodulator
Formulation in More Than 30 Years
DAXXIFY®, the first and only peptide-formulated, long-lasting
neuromodulator, was named as one of TIME’s 2023 Best Inventions.
Unlike conventional neuromodulators, DAXXIFY® is the only
neuromodulator product manufactured exclusively in the U.S. and was
developed to address duration of treatment effect, as nearly 90% of
patients and physicians desire a treatment that lasts longer.1
As the first facial injectable to be selected for this award,
DAXXIFY’s differentiation is clear. With an innovative formulation
and strong performance profile, DAXXIFY®, which is FDA approved for
the temporary improvement of moderate to severe frown lines
(glabellar lines) in adults, is disrupting the $2.5B U.S.
aesthetics neuromodulator market and establishing a new category of
long-acting, peptide-enhanced neuromodulators, creating value for
providers and patients.2
“We are honored to be recognized by TIME® and are encouraged by
the expanding impact of DAXXIFY® in the aesthetics space. By
leveraging research in the emerging field of peptide technology and
after evaluating a number of peptide sequences, Revance developed
an injectable formulation that doesn’t require animal or human
components to stabilize the toxin like competitor products.
DAXXIFY® has demonstrated the ability to deliver high patient
satisfaction stemming from long-lasting results, fast onset and the
appearance of improved skin texture*, providing the first true
innovation in neuromodulator product formulation in over 30 years,”
said Mark Foley, Chief Executive Officer. “The aesthetic facial
injectables market is robust and growing and we are very pleased to
be setting the new standard with DAXXIFY®.”
The efficacy and safety profile of DAXXIFY® is backed by more
than 20 years of research and development and the largest U.S.
Phase 3 clinical program ever conducted for glabellar lines.
DAXXIFY®’s differentiated performance profile is achieved through
its unique formulation, powered by Revance’s proprietary Peptide
Exchange Technology™, a stabilizing peptide excipient which does
not require human or animal-based components. Further, in a recent
independent survey, DAXXIFY® injectors revealed that the product
has additional benefits extending beyond duration, including fast
onset of treatment effect and the appearance of improved skin
smoothness.3
“The launch of DAXXIFY® piqued my interest on many levels,
especially compared to recent conventional neuromodulator
launches,” said Ruth Tedaldi, M.D., founder of Dermatology
Partners. “Over the last year it's been a definite game changer in
my practice as DAXXIFY® provides me with the ability to bring to my
patients what they're asking for – long-lasting results and
improved appearance of skin texture.”
Jody Comstock, M.D., founder of Skin Spectrum, commented,
“DAXXIFY’s unique formulation sets it apart from all conventional
neuromodulators on the market today. As the only neuromodulator
that is stabilized with a peptide rather than human or animal-based
components, I’ve been able to provide my patients with the first
truly differentiated treatment option. The innovation behind
DAXXIFY® combined with the fast onset and long-lasting results has
made it the go-to neuromodulator in my practice.”
DAXXIFY’s label recently expanded in August 2023 to include the
treatment of cervical dystonia, a chronic, debilitating disease in
which the neck muscles contract involuntarily, and has the
potential to deliver significant pharmacoeconomic benefits through
its long-lasting treatment of effect.
* 62% of patients achieved an improvement in skin texture at
week 2 in a phase 2 study
DAXXIFY® (daxibotulinumtoxinA-lanm) injection
IMPORTANT SAFETY INFORMATION INDICATIONS
DAXXIFY® (daxibotulinumtoxinA-lanm) injection is an
acetylcholine release inhibitor and neuromuscular blocking agent
indicated for the temporary improvement in the appearance of
moderate to severe glabellar lines associated with corrugator
and/or procerus muscle activity in adult patients and for the
treatment of cervical dystonia in adults.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DAXXIFY® and all
botulinum toxin products may spread from the area of injection to
produce symptoms consistent with botulinum toxin effects. These
symptoms have been reported hours to weeks after injection.
Swallowing and breathing difficulties can be life threatening and
there have been reports of death. DAXXIFY® is not approved for the
treatment of spasticity or any conditions other than cervical
dystonia and glabellar lines.
IMPORTANT SAFETY INFORMATION
Contraindications DAXXIFY® contraindications include
hypersensitivity to any botulinum toxin preparation or any of the
components in the formulation and infection at the injection
site(s).
Warnings and Precautions Please refer to Boxed Warning
for Distant Spread of Toxin Effect.
The potency units of DAXXIFY® are not interchangeable with
preparations of other botulinum toxin products. Recommended dose
and frequency of administration should not be exceeded. Patients
should seek immediate medical attention if respiratory, speech or
swallowing difficulties occur. Use caution when administering to
patients with pre-existing cardiovascular disease. Concomitant
neuromuscular disorders may exacerbate clinical effects of
treatment.
Adverse Reactions The most commonly observed adverse
reactions are: Glabellar lines (≥1%): headache (6%), eyelid ptosis
(2%) and facial paresis (1%). Cervical dystonia (≥5%): headache
(9%), injection site pain (8%), injection site erythema (5%),
muscular weakness (5%), and upper respiratory tract infection
(5%).
Drug Interactions Co-administration of DAXXIFY® and
aminoglycoside antibiotics, anticholinergic agents or any other
agents interfering with neuromuscular transmission or muscle
relaxants should only be performed with caution as the effect of
DAXXIFY® may be potentiated. The effect of administering different
botulinum neurotoxins during course of treatment with DAXXIFY® is
unknown.
Use in Specific Populations DAXXIFY® is not recommended
for use in children or pregnant women.
Please see DAXXIFY® full Prescribing
Information, including Boxed Warning and Medication
Guide.
To report side effects associated with DAXXIFY®, please visit
safety.revance.com, or call 1-877-373-8669. You may also report
side effects to the FDA at 1-800-FDA-1088 or visit
www.fda.gov/medwatch.
About DAXXIFY®
DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection is the first
and only FDA approved long-lasting, peptide formulated
neuromodulator product with approved indications in the U.S. for
the temporary improvement of glabellar lines (frown lines) and for
the treatment of cervical dystonia in adults. DAXXIFY® is powered
by Peptide Exchange Technology™, Revance's proprietary, synthetic,
35-amino-acid stabilizing excipient, and is developed free of human
serum albumin or animal-based components.1-3 Manufactured in the
U.S., DAXXIFY® is the first true innovation in neuromodulator
product formulation in over 30 years.
About Revance
Revance is a biotechnology company setting the new standard in
healthcare with innovative aesthetic and therapeutic offerings that
enhance patient outcomes and physician experiences. Revance’s
portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for
injection and the RHA® Collection of dermal fillers in the U.S.
Revance has also partnered with Viatris Inc. to develop a
biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun
Pharmaceutical to commercialize DAXXIFY® in China.
Revance is headquartered in Nashville, Tennessee, with
additional office locations in Newark and Irvine, California. Learn
more at www.Revance.com, www.RevanceAesthetics.com,
www.DAXXIFY.com, www.hcp.daxxifytherapy.com, or connect with us on
LinkedIn.
“Revance” and the Revance logo, DAXXIFY®, and OPUL® are
registered trademarks of Revance Therapeutics, Inc. Resilient
Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.
About Cervical Dystonia
Cervical dystonia is a painful condition in which the neck
muscles contract involuntarily, causing abnormal movements and
awkward posture of the head and neck. The movements may be
sustained (tonic), jerky (clonic), or a combination. Cervical
dystonia (also referred to as spasmodic torticollis) may be primary
(meaning that it is the only apparent neurological disorder, with
or without a family history) or may be the result of secondary
causes (such as physical trauma).
First-line treatment for cervical dystonia is usually
neuromodulator (botulinum toxin) injections, but additional
treatments can include oral medications, surgery, and complementary
therapies. Neuromodulators block the communication between the
nerve and the muscle, relaxing the muscle, which alleviates
abnormal involuntary movements and postures. Cervical dystonia can
occur at any age, although most individuals first experience
symptoms in middle age. Roughly 60,000 Americans suffer from this
muscle movement disorder.
Forward-Looking Statements
Any statements in this press release that are not statements of
historical fact, including statements related to the ability of
DAXXIFY® to make the world better, smarter or more enjoyable or
change how we live, work or play; the ability of DAXXIFY® to
disrupt the market; the expanding impact of DAXXIFY®; market size
and growth; our ability to lead the space; injector, consumer and
payer expectations, preferences and behavior; the impact of
DAXXIFY® pricing on injectors, consumers and payers; the potential
benefits and performance of DAXXIFY®; the efficacy, duration,
onset, skin smoothness and safety of DAXXIFY®; the extent to which
DAXXIFY® is considered innovative or differentiated; the
commercialization of DAXXIFY® through our Fosun partnership;
international expansion; development of a biosimilar to
onabotulinumtoxinA for injection with Viatris; and our business and
marketing strategy, timeline and other goals, and plans and
prospects, including our commercialization plans; constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. You should not rely
upon forward-looking statements as predictions of future events.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee that
the future results, levels of activity, performance, events,
circumstances or achievements reflected in the forward-looking
statements will ever be achieved or occur.
Forward-looking statements are subject to risks and
uncertainties that could cause actual results and the timing of
events to differ materially from our expectations. These risks and
uncertainties relate to, but are not limited to: our ability to
obtain funding for our operations; the timing of capital
expenditures; the accuracy of our estimates regarding expenses,
revenues, capital requirements, our financial performance and the
economics of DAXXIFY® and the RHA® Collection of dermal fillers;
our ability to comply with our debt obligations; the impact of
macroeconomic factors on our manufacturing operations, supply
chain, end user demand for our products, commercialization efforts,
business operations, regulatory meetings, inspections and
approvals, clinical trials and other aspects of our business and on
the market; our ability to maintain approval of our products; our
ability and the ability of our partners to manufacture supplies for
DAXXIFY® and our drug product candidates; our ability to acquire
supplies of the RHA® Collection of dermal fillers; the uncertain
clinical development process; our ability to obtain, and the timing
relating to, regulatory submissions and approvals with respect to
our drug product candidates and third-party manufacturers; the risk
that clinical trials may not have an effective design or generate
positive results or that positive results would assure regulatory
approval or commercial success; the applicability of clinical study
results to actual outcomes; the rate and degree of economic
benefit, safety, efficacy, commercial acceptance, market,
competition and/or size and growth potential of DAXXIFY®, the RHA®
Collection of dermal fillers, and our drug product candidates, if
approved; our ability to successfully commercialize DAXXIFY® and to
continue to successfully commercialize the RHA® Collection of
dermal fillers; the timing and cost of commercialization
activities; securing or maintaining adequate coverage or
reimbursement by third-party payors for DAXXIFY®; the proper
training and administration of our products by physicians and
medical staff; our ability to gain acceptance from physicians in
the use of DAXXIFY® for therapeutic indications; our ability to
expand sales and marketing capabilities; the status of commercial
collaborations; changes in and failures to comply with laws and
regulations; our ability to continue obtaining and maintaining
intellectual property protection for our products; the cost and our
ability to defend ourselves in product liability, intellectual
property, class action or other lawsuits; our ability to limit or
mitigate cybersecurity incidents; the volatility of our stock
price; and other risks. Detailed information regarding factors that
may cause actual results to differ materially from the expectations
expressed or implied by statements in this press release may be
found in our periodic filings with the Securities and Exchange
Commission (“SEC”), including factors described in the section
entitled "Risk Factors" in our Form 10-K filed with the SEC on
February 28, 2023, and including, without limitation, our Form
10-Qs for the quarters ended March 31, 2023 and June 30, 2023,
filed with the SEC on May 9, 2023 and August 8, 2023, respectively.
The forward-looking statements in this press release speak only as
of the date hereof. We disclaim any obligation to update these
forward-looking statements.
SOURCES
- Data on File. The Harris Poll Facial Injectables Landmark
Survey Results. Newark, CA: Revance Therapeutics, Inc, 2018.
- Market size as of 2022. CAGRs represent projected estimates.
Decision Resources Group Therapeutic Botulinum Toxin Market
Analysis Global 2023.
- Independent DAXXIFY Survey (N=225), KX Advisors, August
2023.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231026772907/en/
Investors Revance Therapeutics, Inc.: Jessica
Serra, 510-279-6886 jessica.serra@revance.com or
Gilmartin Group, LLC.: Laurence Watts, 619-916-7620
laurence@gilmartinir.com Media Revance
Therapeutics, Inc.: Sara Fahy, 949-887-4476
sfahy@revance.com
Revance Therapeutics (NASDAQ:RVNC)
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