Evolus Announces EMA Acceptance For Review Of The Marketing Authorization Application For DWP-450 Neuromodulator
Published: Jul 20, 2017
SANTA BARBARA, Calif., July 20, 2017 /PRNewswire/ -- Evolus Inc. (www.Evolus.com) received confirmation from the European Medicines Agency (EMA) that the Marketing Authorization Application (MAA) for DWP-450, a Botulinum toxin Type A, for the treatment of adult patients with glabellar lines, also known as "frown lines" between the eyebrows, has been accepted for review.
The MAA application is supported by the results of a Phase III randomized, multi-center, placebo-controlled, double blind trial (EVB-003). Over 500 adult male and female subjects participated in the clinical trial, which is being reviewed under the Centralized Procedure. The Centralized Procedure allows applicants to obtain a marketing authorization that is valid throughout the European Union.
Murthy Simhambhatla, CEO of Evolus, said, "The MAA acceptance for review under the Centralized Procedure is a significant milestone achievement for the DWP-450 development program. We look forward to working with the EMA during the agency's review of the application."
About Evolus Inc.
Evolus Inc. is a privately held company focused on bringing highly innovative products and services to the aesthetics market. Evolus' lead product candidate is DWP-450, a Botulinum toxin Type A for the treatment of glabellar lines.
Evolus Press Contacts:
September Riharb, Vice President, Marketing
Jeff Plumer, Vice President, Legal
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SOURCE Evolus Inc.