Revance Provides Update on DaxibotulinumtoxinA for Injection Pre-Approval Inspection
May 26 2021 - 8:00AM
Business Wire
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
today announced that the FDA plans to initiate its pre-approval
inspection of the company’s manufacturing facility for
DaxibotulinumtoxinA for Injection by the end of June 2021.
In November 2020, Revance received notification from the FDA
that the Agency was deferring a decision on the Biologics License
Application (BLA) for DaxibotulinumtoxinA for Injection for the
treatment of moderate to severe glabellar (frown) lines because the
required pre-approval inspection of the company’s manufacturing
facility could not be completed due to travel restrictions
associated with the COVID-19 pandemic.
About Revance
Revance is a biotechnology company focused on innovative
aesthetic and therapeutic offerings, including its next-generation
neuromodulator product, DaxibotulinumtoxinA for Injection.
DaxibotulinumtoxinA for Injection combines a proprietary
stabilizing peptide excipient with a highly purified botulinum
toxin that does not contain human or animal-based components.
Revance has successfully completed a Phase 3 program for
DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is
pursuing U.S. regulatory approval. Revance is also evaluating
DaxibotulinumtoxinA for Injection in the full upper face, including
glabellar lines, forehead lines and crow's feet, as well as in two
therapeutic indications - cervical dystonia and adult upper limb
spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance
owns a unique portfolio of premium products and services for U.S.
aesthetics practices, including the exclusive U.S. distribution
rights to the RHA® Collection of dermal fillers, the first and only
range of FDA-approved fillers for correction of dynamic facial
wrinkles and folds, and the HintMD fintech platform, which includes
integrated smart payment, subscription and loyalty digital
services. Revance has also partnered with Viatris (formerly Mylan
N.V.) to develop a biosimilar to BOTOX®, which would compete in the
existing short-acting neuromodulator marketplace. Revance is
dedicated to making a difference by transforming patient
experiences. For more information or to join our team visit us at
www.revance.com.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid®
and RHA® are trademarks of TEOXANE SA. BOTOX® is a registered
trademark of Allergan, Inc.
Forward-Looking Statements
Any statements in this press release that are not statements of
historical fact, including statements related to statements about
our ability to obtain, and the timing relating to regulatory
approval with respect to DaxibotulinumtoxinA for Injection in
glabellar lines; the timing and outcome of the FDA’s inspection of
the Northern California manufacturing facility; the commercial
launch of DaxibotulinumtoxinA for Injection; and development of a
biosimilar to BOTOX® with our partner, Viatris, 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: the results, timing, costs, and completion of
our research and development activities and regulatory approvals,
including the continuing delay in the FDA’s approval of the BLA for
DaxibotulinumtoxinA for Injection for the treatment of glabellar
lines, including as a result of observations made by the FDA during
the site inspection or other reasons; the impact of the COVID-19
pandemic on our manufacturing operations, supply chain, end user
demand for our products, commercialization efforts, business
operations, clinical trials and other aspects of our business; our
ability to manufacture supplies for our product candidates; the
uncertain clinical development process; the risk that clinical
trials may not have an effective design or generate positive
results; the applicability of clinical study results to actual
outcomes; the rate and degree of economic benefit, the safety,
commercial acceptance and the market, competition, size and growth
potential of our services and our drug product candidates, if
approved; our ability to successfully commercialize our services
and our drug product candidates, if approved, and the timing and
cost of commercialization activities; our ability to develop sales
and marketing capabilities; the status of commercial
collaborations; our ability to obtain funding for our operations;
our ability to continue obtaining and maintaining intellectual
property protection for our drug product candidates; and our
financial performance, including future revenue, expenses and
capital requirements. 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-Q for the quarter ended
March 31, 2021, filed with the SEC on May 10, 2021. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210526005354/en/
Investors Revance: Jessica Serra, 626-589-1007
jessica.serra@revance.com or Gilmartin Group, LLC.: Laurence Watts,
619-916-7620 laurence@gilmartinir.com Media Revance: Sara
Fahy, 949-887-4476 sfahy@revance.com or General Media: Y&R:
Jenifer Slaw, 347-971-0906 jenifer.slaw@YR.com or Trade Media:
Nadine Tosk, 504-453-8344 nadinepr@gmail.com
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