Revance Provides Regulatory Update on DaxibotulinumtoxinA for Injection for the Treatment of Moderate to Severe Glabellar (Frown) Lines
Revance Therapeutics (NASDAQ: RVNC) announced a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, intended for treating moderate to severe glabellar lines. Received on October 15, the CRL indicates deficiencies found during the FDA's inspection of Revance's manufacturing facility. Revance plans to request a Type A meeting with the FDA to address these issues. CEO Mark Foley expressed disappointment at this unexpected response but reiterated the company's commitment to launching their neuromodulator product.
- None.
- FDA issued a Complete Response Letter (CRL) regarding the BLA for DaxibotulinumtoxinA, delaying approval.
- Deficiencies were identified during the FDA’s inspection of the manufacturing facility, impacting the approval process.
In a communication received on
“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
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
“Revance Therapeutics” and the Revance logo are registered trademarks of
Resilient Hyaluronic Acid® and RHA® are trademarks of
BOTOX® is a registered trademark of
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
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Media
Revance:
sfahy@revance.com
Investors
Revance:
Jessica.serra@revance.com
or
laurence@gilmartinir.com
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FAQ
What did the FDA say about Revance's DaxibotulinumtoxinA on October 15?
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