Reported Late Friday, Revance Announces U.S. FDA Acceptance Of Supplemental Biologics License Application For DAXXIFY For Injection For The Treatment Of Cervical Dystonia

- Prescription Drug User Fee Act (PDUFA) date of August 19, 2023 -

Revance Therapeutics, Inc. (NASDAQ:RVNC) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults, a chronic and debilitating neurologic condition affecting the muscles of the neck.1 Revance was provided a Prescription Drug User Fee Act (PDUFA) date of August 19, 2023.

DAXXIFY®, the first and only peptide formulated neuromodulator, which was approved by the FDA for the temporary improvement of moderate to severe glabellar lines in adults, was evaluated in two Phase 3 clinical studies for cervical dystonia: ASPEN-1, a randomized, double-blind, placebo-controlled, parallel group trial, and ASPEN-OLS, an open-label, repeat dose, long-term safety trial.

"Positive results from our ASPEN Phase 3 clinical program demonstrate the potential of DAXXIFY® to bring sustained symptom relief to cervical dystonia patients, along with the potential for reduced frequency of annual injections," said Mark J. Foley, Chief Executive Officer. "With the FDA's acceptance of our sBLA and our upcoming PDUFA date in August 2023, we are one step closer to setting a new standard of care for cervical dystonia patients, where botulinum toxins are considered a first line treatment."

In the pivotal ASPEN clinical program, DAXXIFY® was shown to be effective, generally safe and well tolerated across both dose groups, 125U and 250U, and clinically meaningful improvement was observed by both patients and clinicians, compared to placebo, with a median duration of effect of 24.0 and 20.3 weeks, for the two dose groups respectively. Results from the ASPEN-OLS study reinforced the safety findings reported from ASPEN-1 study, as well as the efficacy of DAXXIFY® with up to four repeat treatments.

"Painful symptom re-emergence is very common for patients with cervical dystonia and up until now physicians have not been able to fully address this issue with existing treatment options," said Peter McAllister, MD. "As an ASPEN investigator, I am excited about the results of the DAXXIFY® Phase 3 trials, which demonstrate that a long-acting botulinum toxin can help address this significant unmet need in the treatment of cervical dystonia."

The FDA's acceptance of the company's sBLA advances Revance's opportunity in the nearly $1.0 billion, U.S. muscle movement disorder market, which includes both cervical dystonia and spasticity. 2-3

INDICATION

DAXXIFY® (daxibotulinumtoxinA-lanm) for 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.

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 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 (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).

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.

About DAXXIFY®

DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection is the first and only FDA approved long-lasting peptide-formulated neuromodulator product for use in adults for the temporary improvement of moderate to severe frown lines (glabellar lines). 4-5,10-14 DAXXIFY® has the ability to deliver year-long results for patients with potentially only two treatments per year and has been proven to be effective, and generally safe and well tolerated.5-8* DAXXIFY® is powered by a cell-penetrating peptide technology (Peptide Exchange Technology™), Revance's proprietary, synthetic, 35-amino-acid stabilizing excipient with a highly positive charge, and is free of human serum albumin or animal-based components. 4,5,14 Manufactured exclusively in the U.S., DAXXIFY® is the first true innovation in neuromodulator product formulation in over 30 years.

Revance has evaluated this neuromodulator formulation in other Phase 2 clinical studies in aesthetics, including the full upper face, forehead lines and crow's feet as well as in therapeutic indications, including cervical dystonia and upper limb spasticity. Learn more at RevanceAesthetics.com.

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. Current neuromodulator treatments for cervical dystonia have a duration of effect of approximately three months. Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects a few hundred thousand adults and children in the United States alone. The U.S. and global market opportunities for cervical dystonia are approximately $325 million and $438 million, respectively as of 2021.2 The U.S. and global market opportunities for treating muscle movement disorders with botulinum toxins, which include cervical dystonia and spasticity (upper and lower limb), are approximately $929 million and $1.2 billion, respectively as of 2022.2