– Two presentations highlighting data on DAXXIFY® for the
treatment of cervical dystonia, including a new analysis from ASPEN
trials assessing patient-desired retreatment intervals and one
abstract examining the influence of DAXXIFY’s formulation on
clinical performance
Revance Therapeutics, Inc. (NASDAQ: RVNC), today announced two
poster presentations on DAXXIFY® for the treatment of cervical
dystonia at the annual meeting of American Academy of Neurology
(AAN), taking place April 13-18, 2024, in Denver, Colorado.
In the ASPEN-1 and ASPEN-OLS (open label study), a new analysis
found that among patients that requested early retreatment with
DAXXIFY®, roughly 50% of peak efficacy remained at the time of
their request. In the ASPEN-OLS 52-week long-term follow-up study,
approximately 60% of retreatments were at 16 weeks or later. These
findings suggest that the long-acting symptom control with DAXXIFY®
allows physicians the flexibility to customize treatment intervals
for each patient, without being limited by the FDA and
payer-defined minimum treatment interval of 12 weeks (as is the
case with conventional neurotoxins). Additionally, the studies show
that adverse event rates remained low across all retreatment
scenarios.
“While it may not be surprising that many patients prefer to be
retreated as their symptoms first re-emerge rather than waiting to
return to baseline, we believe that the duration of DAXXIFY offers
the potential for physicians to tailor doses and retreatment
intervals to the needs of individual patients, in order to provide
sustained symptom control and reduce the symptom rollercoaster
experienced by a vast number of those suffering with cervical
dystonia,” said David. A. Hollander, MD, MBA, Chief Medical Officer
and Global Therapeutics Franchise Lead.
A second poster, by Dr. Han Lee and colleagues, examines
DAXXIFY’s novel formulation and the role of Revance’s
custom-engineered peptide (RTP004), in clinical performance. The
data shows that the benefits of RTP004 include increased binding of
neurotoxin to cell membranes to allow more toxin to enter the
neuron, enhanced SNAP-25 cleavage in neurons in a dose-dependent
manner, and localization in the injected muscle. By increasing
bioavailability, DAXXIFY’s formulation allows for a lower amount of
core neurotoxin to be administered while maintaining long lasting
benefit, which may contribute to the strong safety and
differentiated performance profile.
Poster Details:
- Title: Efficacy Remaining at Time of Requested
Retreatment Following Botulinum Toxin Treatment for Cervical
Dystonia: Potential for a New Treatment Paradigm With
DaxibotulinumtoxinA
- Authors and Affiliation: Aaron Ellenbogen, Robert A.
Hauser, Atul Patel, Peter McAllister, Domenico Vitarella, Todd
Gross, Rashid Kazerooni, Conor J. Gallagher, David A. Hollander,
Michigan Institute for Neurological Disorders, Farmington Hills,
MI, USA; University of South Florida, Tampa, FL, USA; Kansas City
Bone & Joint Clinic, Overland Park, KS, USA; New England
Institute for Neurology and Headache, Stamford, CT, USA; Revance
Therapeutics, Inc., Nashville, TN, USA
- Title: Influence of Novel Formulation in
DaxibotulinumtoxinA on Efficacy for Treatment of Cervical
Dystonia
- Authors and Affiliation: Han Lee, André F. Batista,
Conor J. Gallagher, The Permanente Medical Group, San Leandro, CA,
USA; Revance Therapeutics, Inc., Nashville, TN, USA
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.
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.1-5 Manufactured in the
U.S., DAXXIFY is the first true innovation in neuromodulator
product formulation in over 30 years.
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.
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 (including treatment
intervals) of DAXXIFY® for the treatment of cervical dystonia; our
opportunity in aesthetics and therapeutics; the potential to set a
new standard in healthcare; patient outcomes and physician
experiences; 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, supply chain and operational
efficiencies; 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, 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; 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 for the year ended
December 31, 2023, filed with the SEC on February 28, 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
- Comella C, Ferreira JJ, Pain E, Azoulai M, Om S. Patient
perspectives on the therapeutic profile of botulinum neurotoxin
type A in cervical dystonia. J Neurol 2020;268:903-912.
- Data on file. ASPEN CSR. Revance. Newark, CA: Revance
Therapeutics, Inc., 2018.
- DAXXIFY. Prescribing Information. Revance Therapeutics, Inc,
2022.
- Fabi SG, Cohen JL, Green LJ, et al. DaxibotulinumtoxinA for
Injection for the treatment of glabellar lines: efficacy results
from SAKURA 3, a large, open label, phase 3 safety study. Dermatol
Surg. 2020;47(1):48-54.
- Waugh JM, Lee J, Dake MD, Browne D. Nonclinical and clinical
experiences with CPP-based self-assembling peptide systems in
topical drug development. Methods Mol Biol. 2011;683:553-572.
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version on businesswire.com: https://www.businesswire.com/news/home/20240412360245/en/
Investors Laurence Watts, 619-916-7620
laurence@newstreetir.com
Media Revance@evolvemkd.com
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