Products
Aesthetics Clinical ProgramUpdate
PIPELINE
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PHASE 1
PHASE 2
PHASE 3
AESTHETICS
DAXXIFY® (DaxibotulinumtoxinA-lanm) injection
Glabellar (frown) lines
FDA Approved
Forehead lines
Lateral canthal lines
Upper facial lines
Positive results in all three open label Phase 2 studies to evaluate dosing and injection patterns
OTHER
Neuromodulators
Biosimilar to BOTOX®
Topical
Partnered with Viatris, Inc.
Neuromodulator Uses
- A – Glabellar (Frown) Lines
- B – Forehead Lines
- C – Lateral Canthal Lines (Crow’s Feet)
- A, B, C – Upper Facial Lines
DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection was approved in September 2022 for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults. DaxibotulinumtoxinA for Injection has also been evaluated in a Phase 2 head-to-head, active comparator study (BELMONT). DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA and is currently under regulatory review.
DAXXIFY® for Injection was evaluated in a Phase 2 open-label study for the treatment of moderate to severe dynamic forehead lines (frontalis) following glabellar line injection. An interim analysis from the study found that treatment with DAXXIFY® for Injection substantially improved the appearance of forehead lines versus placebo at all doses tested 4 weeks after treatment and resulted in high patient satisfaction.1
Lateral canthal lines, commonly known as crow’s feet, are associated with a combination of muscle movement, loss of volume around the eyes, skeletal changes and a reduction in skin quality.3 DAXXIFY® for Injection was evaluated in a Phase 2 open-label study for the treatment of moderate to severe lateral canthal lines, commonly known as crow’s feet. Clinical data demonstrated positive efficacy results and that DAXXIFY® for Injection was well tolerated.
Revance evaluated DAXXIFY® for Injection in an open-label Phase 2 study for treatment of the full upper face, including glabellar (frown) lines, forehead lines and crow’s feet (lateral canthal lines). The study was conducted to understand the safety and efficacy, including potential dosing and injection patterns, of DAXXIFY® for Injection. In December 2020, Revance announced positive topline efficacy and safety results from its Phase 2 study. For the latest information regarding our clinical development programs, please see our public filings with the Securities and Exchange Commission or visit clinicaltrials.gov.
References
1 – Nowell Solish, et al. A Phase 2a Dose-Escalation Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Dynamic Forehead Lines Following Glabellar Line Injections: An Interim Analysis. Poster presentation at 2020 Annual Maui Derm for Dermatologists meeting. 25-29 January 2020. Maui, Hawaii.
2 – Tung, R, et al., Treatment of lateral canthal rhytides with a medium depth chemical peel with or without pretreatment with onabotulinum toxin type A: a randomized control trial. International Journal of Women’s Dermatology, Volume 2, Issue 1, 1 March 2016, Pages 31-34.
3 – US Food and Drug Administration Guidance Document. Upper Facial Lines: Developing Botulinum Toxin Drug Products Available at: https://www.fda.gov/media/89195/download (2014), Accessed Aug 2019
IMPORTANT SAFETY INFORMATION for DAXXIFY® (daxibotulinumtoxinA-Ianm) for injection
Indications
(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 other 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:
Glabeller lines (≥1%) were 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
DAXI-004726
