- CMS streamlines reimbursement for DAXXIFY
with assignment of permanent J-code -
- Peer-reviewed publication of DAXXIFY pivotal
data in therapeutics reinforces the products long duration of
effect and favorable safety profile -
Revance Therapeutics, Inc. (RVNC) today announced that the U.S.
Centers for Medicare & Medicaid Services (CMS) has assigned a
permanent J-code (J0589) for DAXXIFY®, indicated for the treatment
of cervical dystonia in adults. J-Codes are product-specific
reimbursement codes used by commercial insurance plans, Medicare,
and other government payers and are intended to simplify
reimbursement for providers and expand access for patients.
The company also announced today the publication of results from
the ASPEN-1 Pivotal Phase 3 study in Neurology®, the medical
journal of the American Academy of Neurology. The study, authored
by Cynthia L. Comella, M.D., evaluated the safety, duration of
response, and efficacy of two doses of DAXXIFY for the treatment of
cervical dystonia (CD), and served as the foundation for Food and
Drug Administration (FDA) approval of DAXXIFY for the treatment of
cervical dystonia in August 2023.
“We are very pleased to receive our permanent J-Code for DAXXIFY
as we continue to make great progress with our cervical dystonia
PrevU program and prepare for launch,” said Mark J. Foley, Chief
Executive Officer. “Thanks to the hard work of our therapeutics
team, we have received our reimbursement code, secured coverage for
over 100 million commercial lives from top payers across the
country and are on track to commercialize DAXXIFY in the
therapeutics market mid-year. Further, our confidence in DAXXIFY’s
ability to deliver a favorable duration and safety profile in
real-world cervical dystonia patients continues to grow based on
positive feedback from our PrevU physicians and the over 250
patients that have been treated to date in the PrevU program. Based
on DAXXIFY’s unique clinical profile, our early clinical experience
and advances in our reimbursement and coverage efforts, we look
forward to providing patients suffering from cervical dystonia with
a compelling alternative to their conventional treatment
options.”
“As an investigator in all stages of the ASPEN program and a
participating physician in the DAXXIFY CD PrevU program, I’m happy
to see publication of the pivotal study results in a peer-reviewed
journal for the neurology community,” said Atul Patel, M.D., MHSA.
“Importantly, the real-world clinical results of DAXXIFY from the
patients I have injected so far in PrevU, including safety,
efficacy and duration, are in-line with those seen in the ASPEN-1
study. By offering a long duration of treatment effect, DAXXIFY can
help reduce symptom reoccurrence between injections, which is
experienced by most patients being treated with conventional
botulinum toxins. This would represent a significant advancement in
the treatment of cervical dystonia, something we have not seen in
decades.”
The pivotal Phase 3 clinical study (ASPEN 1), included 301
patients randomized to receive 125 U or 250U of DAXXIFY, or to
placebo.1-2 DAXXIFY was shown to be effective, generally safe, and
well tolerated across both dose groups, 125U and 250U. 1-2 The
primary endpoint was met in both groups, with 12.7 and 10.9 point
reductions from baseline in Total TWSTRS score averaged over Weeks
4 and 6 (p<0.01 vs placebo).1-2 Median duration of effect,
defined as >80% loss of peak effect, was 24.0 and 20.3 weeks for
the two dose groups respectively. 1-2 The low incidence rates of
dysphagia (1.9% and 3.6%, respectively) and muscle weakness (4.7%
and 2.3%, respectively), further support DAXXIFY’s safety
profile.1-2 The Phase 3 clinical program also included a
repeat-treatment, open-label safety study (ASPEN OLS) that allowed
for up to 4 additional DAXXIFY treatments, which reinforced the
findings of ASPEN-1.3
The total U.S. therapeutic neuromodulator market opportunity for
DAXXIFY is $2.7 billion, which includes the over $350 million
cervical dystonia market.4
The full publication can be accessed via Neurology.org.
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.1-2, 5-7
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 is headquartered in Nashville, Tenn., with additional
office locations in Newark and Irvine, Calif. Learn more at
www.Revance.com, www.RevanceAesthetics.com,
www.DAXXIFY.com, https://hcp.daxxifytherapy.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 patient access and physician reimbursement
for DAXXIFY® for cervical dystonia; our market opportunity; the
potential benefits, safety, efficacy and duration of DAXXIFY®; our
opportunity in therapeutics; the extent to which our products are
unique or innovative; the potential to set a new standard of care;
development of a biosimilar to BOTOX® with our partner, Viatris;
statements about our business strategy, timeline and other goals,
plans and prospects, including with respect to DAXXIFY®; the
possibility for international commercialization; and the outcomes
for and experiences of patients and physicians, including with
respect to real world results remaining consistent with study
results; 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 to differ materially
from our expectations. These risks and uncertainties relate, 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 "Risks Factors"
on 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, June 30, 2023 and September 30, 2023, filed
with the SEC on May 9, 2023, August 8, 2023 and November 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
- 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.
- Data on file. ASPEN OLS CSR. Revance. Newark, CA: Revance
Therapeutics, Inc., 2018
- Market size as of 2023. CAGRs represent projected estimates.
Decision Resources Group Therapeutic Botulinum Toxin Market
Analysis Global 2024.
- 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/20240202009510/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.: Cathryn Castaldo, +1
(615)-245-7567 Cathryn.Castaldo@revance.com
Revance Therapeutics (NASDAQ:RVNC)
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