– 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.
NASHVILLE, Tenn.–(BUSINESS WIRE)–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
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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.
Contacts
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