- DAXXIFY® for the treatment of cervical dystonia is the first
and only peptide-formulated, long-lasting neurotoxin that offers
the potential to improve duration of symptom control1
- Revance has received a Permanent J-Code and has already secured
coverage for 78% of commercial lives with top health plans, while
also launching patient affordability programs
- Today’s launch provides first entry into the $2.7 billion U.S.
therapeutic neurotoxin market with a new and compelling treatment
option2
Revance Therapeutics, Inc. (NASDAQ: RVNC), today announced the
commercial launch of DAXXIFY (DaxibotulinumtoxinA-lanm) for
injection for the treatment of cervical dystonia, providing
patients and physicians with a compelling new treatment option for
a painful and disabling chronic condition. The launch marks
Revance’s entry into the large and growing U.S. therapeutics
neurotoxin market.
“DAXXIFY provides a significant opportunity for Revance and
marks the culmination of our decades-long mission to bring true
innovation to the therapeutics market. Between DAXXIFY’s
differentiated clinical profile, compelling value proposition and
safety profile, DAXXIFY has the potential to address the unmet
needs of all stakeholders, including patients, physicians and
payers,” said President and Chief Executive Officer, Mark J.
Foley.
Following the FDA’s approval of DAXXIFY for cervical dystonia in
August 2023, Revance launched the DAXXIFY cervical dystonia PrevU
early experience program with the objective of optimizing treatment
outcomes for patients and ensuring smooth practice integration.
Revance subsequently established its commercial infrastructure in
preparation for launch, received a permanent J-Code for DAXXIFY
from the U.S. Centers for Medicare & Medicaid Services (CMS)
(which streamlines the reimbursement pathway for providers),
operationalized reimbursement support services to minimize
potential hurdles to adoption, and launched patient affordability
programs to support patients with out-of-pocket costs.
“One of our primary goals has been to minimize barriers and
ensure access to DAXXIFY for the large number of CD patients who
have early symptom re-emergence and are not adequately controlled
on current toxin treatments,” said David. A. Hollander, M.D., MBA,
Chief Medical Officer and Global Therapeutics Franchise Lead.
Peter McAllister, M.D., co-founder and medical director of the
New England Institute for Neurology and Headache, added: “As an
investigator in the ASPEN program, and a participating physician in
PrevU, I have seen firsthand the potential for DAXXIFY to address a
significant unmet need in the treatment of cervical dystonia. Many
patients struggle with pain and discomfort coming back between
injections with current treatment options, but with DAXXIFY my
patients have experienced long lasting symptom relief. Further,
DAXXIFY’s safety profile continues to be encouraging over a broad
range of doses. As patients can currently only access treatment
every 12 weeks based on product labeling and reimbursement
guidelines, I’m excited to offer my patients a new therapy that
offers sustained symptom control.”
For more information on DAXXIFY® access and availability, visit
HCP.DAXXIFYCervicalDystonia.com
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. Manufactured in the U.S.,
DAXXIFY is the first true innovation in neuromodulator product
formulation in over 30 years.
Please see DAXXIFY important safety information below and full
Prescribing Information, including Boxed Warning and Medication
Guide.
About Cervical Dystonia
According to the Dystonia Medical Research Foundation, 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. The condition affects roughly 60,000 people
in the United States.
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’s global headquarters and experience center is located
in Nashville, Tennessee. Learn more at Revance.com,
RevanceAesthetics.com, DAXXIFY.com,
HCP.DAXXIFYCervicalDystonia.com, or connect with us on
LinkedIn.
“Revance”, the Revance logo, and DAXXIFY are registered
trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid®
and RHA are trademarks of TEOXANE SA.
Forward-Looking Statements
Any statements in this press release that are not statements of
historical fact, including statements related to the potential
benefits, safety, efficacy and duration of DAXXIFY® for the
treatment of Cervical Dystonia; our opportunity in therapeutics;
the U.S. therapeutics neurotoxin market; patient, physician and
payor outcomes and experiences; our ability to set a new standard
in healthcare; development of an onobotulinumtoxinA biosimilar with
our partner, Viatris; and commercialization of DAXXIFY® in China
with our partner, Shanghai Fosun Pharmaceutical; 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, cost savings related to the
divestiture of the OPUL payments business and supply chain and
operational efficiencies; our financial performance and the
economics of DAXXIFY and the RHA Collection of dermal fillers; the
extent of future impairment charges; 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, duration, 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 payers for DAXXIFY; the proper training and
administration of our products by physicians and medical staff; our
ability to maintain and gain acceptance from injectors and
physicians in the use of DAXXIFY for aesthetic and therapeutic
indications; our ability to strengthen professional partnerships;
our ability to expand sales and marketing capabilities; the status
of commercial collaborations; our ability to effectively manage the
exit of the OPUL payments business; 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
results 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, 2024, and including, without limitation, our Form
10-Q for the quarter ended March 31, 2024, expected to be filed
with the SEC on May 9, 2024. 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. ASPEN-1 Rollover and ASPEN OLS TWSTRS. Newark,
CA: Revance Therapeutics, Inc.
- Market size as of 2023. CAGRs represent projected estimates.
Decision Resources Group Therapeutic Botulinum Toxin Market
Analysis Global 2024.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240509592752/en/
Investors Laurence Watts, 619-916-7620
laurence@newstreetir.com
Media Revance@evolvemkd.com
Grafico Azioni Revance Therapeutics (NASDAQ:RVNC)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni Revance Therapeutics (NASDAQ:RVNC)
Storico
Da Dic 2023 a Dic 2024
