Revance Continues to Anticipate FDA Approval of DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines in 2021
October 12 2021 - 7:10PM
Business Wire
- BLA for DaxibotulinumtoxinA for Injection
remains under FDA review -
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
responds to the public disclosure of its Form 483 pursuant to a
Freedom of Information Act (FOIA) request that was directed to the
FDA. The Biologics License Application (BLA) for
DaxibotulinumtoxinA for Injection remains under FDA review and the
company continues to anticipate FDA approval of DaxibotulinumtoxinA
for Injection for the treatment of glabellar lines in 2021.
Revance notes that the issuance of a Form 483 following the
conclusion of an on-site inspection is not uncommon. A Form 483
lists observations made by FDA representatives during the
inspection of a facility. A Form 483 does not constitute a final
agency determination.
Revance provided its response to the Form 483 in July 2021
following a pre-approval inspection and is currently awaiting the
FDA’s decision on its BLA for DaxibotulinumtoxinA for Injection for
the treatment of glabellar lines. The company remains confident in
the quality of its BLA submission and continues to anticipate FDA
approval in 2021.
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 OPUL™ Relational Commerce Platform.
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 our ability to
obtain and the timing relating to FDA approval of our BLA for
DaxibotulinumtoxinA for Injection for the treatment of glabellar
lines; our confidence in the quality of our BLA submission; the
status of our BLA submission; the outcome of the FDA’s inspection
of the company’s Northern California manufacturing facility 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 and
on the market; our ability to manufacture supplies for our product
candidates and to acquire supplies of the RHA® Collection of dermal
fillers; the uncertain clinical development process; 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, the safety, efficacy, commercial acceptance and the
market, competition, size and growth potential of OPUL™, the RHA®
Collection of dermal fillers and our dug product candidates, if
approved; our ability to continue to successfully commercialize the
RHA® Collection of dermal fillers and OPUL™ and our ability to
successfully commercialize DaxibotulinumtoxinA for Injection, if
approved, and the timing and cost of commercialization activities;
our ability to expand sales and marketing capabilities; the status
of commercial collaborations; our ability to obtain funding for our
operations; the cost and our ability to defend ourselves in product
liability, intellectual property and other lawsuits; our ability to
continue obtaining and maintaining intellectual property protection
for our drug product candidates; our financial performance,
including future revenue, expenses and capital requirements; 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 25, 2021 and
including, without limitation, our Form 10-Q for the quarter ended
June 30, 2021, filed with the SEC on August 5, 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/20211012006215/en/
Investors Revance Therapeutics, Inc.: Jessica Serra,
626-589-1007 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 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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