Treatment for Glabellar Lines
Evolus Receives Conditional FDA Acceptance of Jeuveau Brand Name
IRVINE, Calif., Nov. 19, 2018 (GLOBE NEWSWIRE) — Evolus, Inc. (NASDAQ: EOLS), a company dedicated to aesthetic medicine, today announced the conditional acceptance from the U.S. Food and Drug Administration (“FDA”) of the Jeuveau™ brand name for its lead product candidate DWP-450 (prabotulinumtoxinA) and its premier partnership with The American Society for Aesthetic Plastic Surgery (ASAPS). In the coming months, Evolus plans to accelerate its transition from an R&D to a commercial stage company.
Michael Jafar, Chief Marketing Officer of Evolus, stated, “The unveiling of the Jeuveau brand and our partnership with key medical societies are significant milestones as we advance towards commercialization in anticipation of a Spring 2019 U.S. commercial launch.”
W. Grant Stevens, MD, President of The American Society for Aesthetic Plastic Surgery, commented, “We are thrilled to partner with Evolus. As a society we value innovation and look forward to the introduction of Jeuveau as a new option in the medical aesthetics market.”
Final approval of the Jeuveau brand name is conditional on the FDA approval of DWP-450. The FDA has assigned DWP-450 a February 2, 2019 action date per the Prescription Drug User Fee Act (PDUFA).
About Evolus, Inc.
Evolus is a company dedicated to aesthetic medicine focused on providing physicians and their patients with expanded choices in aesthetic treatments and procedures. Evolus’ lead candidate DWP-450, also known by the chemical name prabotulinumtoxinA, is a 900 kDa purified botulinum toxin type A complex that was approved by Health Canada for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients under 65 years of age and is being evaluated for marketing approval in the United States and other areas.
The American Society for Aesthetic Plastic Surgery (ASAPS) is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and nonsurgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “planned,” “expect,” “believes,” “strategy,” “opportunity,” “anticipates,” “outlook,” “designed,” and similar words. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Evolus’ periodic filings with the Securities and Exchange Commission, including factors described in the section entitled ”Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2017 and its Quarterly Report on Form 10-Q for the Quarter ended September 30, 2018, as filed with the Securities and Exchange Commission on March 29, 2018 and November 5, 2018, respectively, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Evolus undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.
Posted: November 2018
Jeuveau (prabotulinumtoxinA) FDA Approval History