Revance Provides Regulatory Update on DaxibotulinumtoxinA for Injection for the Treatment of Moderate to Severe Glabellar (Frown) Lines
October 15 2021 - 5:10PM
Business Wire
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
today announced that the United States (U.S.) Food and Drug
Administration (FDA) has issued a Complete Response Letter, or CRL,
regarding the Biologics License Application (BLA) for
DaxibotulinumtoxinA for Injection, for the treatment of moderate to
severe glabellar (frown) lines.
In a communication received on October 15, the FDA has
determined it is unable to approve the BLA in its present form, and
indicated that there are deficiencies related to the FDA’s onsite
inspection at Revance’s manufacturing facility. Revance plans to
request a Type A meeting with the FDA as soon as possible to
address the deficiencies raised. No other deficiencies were
identified in the CRL.
“We are very disappointed by this unanticipated response from
the FDA and are seeking further clarity from the agency. We remain
committed to bringing our next-generation neuromodulator product to
market in both aesthetic and therapeutic indications,” said Mark
Foley, President and Chief Executive Officer.
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
This press release contains forward-looking statements,
including statements related to statements about our ability to
obtain, and the timing relating to the Type A meeting with the FDA
with respect to DaxibotulinumtoxinA for Injection; our ability to
address the deficiencies raised and obtain approval of and
commercialize DaxibotulinumtoxinA for Injection for aesthetic or
therapeutic indications; development of a biosimilar to BOTOX®; and
statements about our business strategy, timeline and other goals,
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 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 our ability to obtain FDA 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, regulatory approvals, clinical trials and other aspects
of our business and on the market; our ability and the ability of
our partners 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 the RHA® Collection of
dermal fillers, OPUL™, and our drug 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; changes in and failures to comply
with privacy and data protection laws; our ability to effectively
manage our expanded operations in connection with the acquisition
of Hint, Inc; our ability to obtain funding for our operations; our
ability to continue obtaining and maintaining intellectual property
protection for our drug product candidates; the accuracy of our
estimates regarding expenses, future revenues, capital
requirements, our financial performance and the economics of
DaxibotulinumtoxinA for Injection; the cost and our ability to
defend ourselves in product liability, intellectual property or
other lawsuits; 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/20211015005626/en/
Media Revance: Sara Fahy, 949-887-4476
sfahy@revance.com
Investors Revance: Jessica Serra, 626-589-1007
Jessica.serra@revance.com or Gilmartin Group, LLC.: Laurence Watts,
619-916-7620 laurence@gilmartinir.com
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