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 deferred a decision on the Biologics
License Application (BLA) for DaxibotulinumtoxinA for Injection, an
investigational neuromodulator product for the treatment of
moderate to severe glabellar (frown) lines.
In a communication received on November 24, 2020, the FDA
reiterated that an inspection of the company’s manufacturing
facility is required as part of the BLA approval process. The
Agency was unable to conduct a required inspection of the company’s
Northern California manufacturing facility due to the Agency’s
travel restrictions associated with the COVID-19 pandemic. Revance
confirmed with the FDA that their communication was not a Complete
Response Letter.
Though the company’s BLA is still under review, the FDA did not
indicate there are any other review issues at this time, beyond the
on-site inspection. The FDA stated they are actively working to
define an approach for scheduling outstanding inspections, once
safe travel may resume and based on public health need and other
factors.
“We appreciate FDA’s engagement on the Chemistry, Manufacturing
and Controls (CMC), non-clinical, clinical and labeling sections of
our BLA, particularly given the unique and unprecedented situation
we are in as a result of the COVID-19 pandemic. We look forward to
continued interaction with the Agency and remain ready to support
FDA’s pre-approval inspection as soon as possible. We are fortunate
that we manufacture our product at a single location in the U.S.,
which should put us at an advantage compared to international
manufacturing locations once travel resumes,” said Mark J. Foley,
President and Chief Executive Officer. “As stated in our third
quarter earnings, with the addition of the RHA® Collection of
dermal fillers and acquisition of the HintMD fintech platform
earlier this year, we believe the company is in an excellent
position, both commercially and financially, to weather a change to
the timing of this potential approval.”
DaxibotulinumtoxinA for Injection is an investigational agent
that combines a proprietary stabilizing peptide excipient with a
highly purified botulinum toxin that does not contain human or
animal-based components. In the first quarter of 2020, Revance
announced that the BLA for DaxibotulinumtoxinA for Injection had
been accepted for review by the FDA and the company had been given
a Prescription Drug User Fee Act (PDUFA) target action date of
November 25, 2020. The submission was based on results from the
largest aesthetic neuromodulator clinical program ever conducted
for the treatment of glabellar (frown) lines, including the SAKURA
1, 2 and 3 Phase 3 clinical studies.
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. 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 Statement: Revance Therapeutics
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 and the expected PDUFA date; the inspection by the
FDA of our manufacturing facility in connection with the BLA
approval process, including the timing and outcome of and factors
impacting the inspection; our financial performance; our commercial
potential; 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 and timing of our regulatory
approvals; delays in the approval of our BLA for
DaxibotulinumtoxinA for Injection for the treatment of glabellar
lines due to COVID-19-related policies and travel restrictions
currently in place at the FDA; 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 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; the
applicability of clinical study results to actual outcomes; our
ability to obtain regulatory approval of our drug product
candidates; whether the HintMD acquisition and Teoxane agreement
will provide the anticipated economic and other benefits; the rate
and degree of commercial acceptance and the market, size and growth
potential of the RHA® Collection of dermal fillers, the HintMD
payments platform and our drug product candidates, if approved; our
ability to successfully commercialize the RHA® Collection of dermal
fillers, the HintMD payments platform 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 filed with the SEC on November 9, 2020. 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.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20201125005462/en/
Media Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476
sfahy@revance.com or General Media Goodfuse Jenifer Slaw,
347-971-0906 jenifer.slaw@Goodfuse.com or Trade Media Nadine
Tosk, 504-453-8344 nadinepr@gmail.com Investors Revance
Therapeutics, Inc.: Jeanie Herbert, 714-325-3584
jherbert@revance.com or Gilmartin Group, LLC.: Laurence Watts,
619-916-7620 laurence@gilmartinir.com
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