Evolus Announces FDA Acceptance for Review of the Biologics License Application for DWP-450 Neuromodulator
- Category: Proteins and Peptides
- Published on Wednesday, 19 July 2017 18:26
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New 900 kDa Botulinum toxin Type A
SANTA BARBARA, CA, USA I July 19, 2017 I Evolus Inc. (www.Evolus.com) received confirmation from the U.S. Food and Drug Administration (FDA) that their Biologics License Application (BLA) for DWP-450, a new 900 kDa Botulinum toxin Type A, has been accepted for review. The BLA is for the treatment of adult patients with glabellar lines, also known as "frown lines" between the eyebrows.
The BLA candidate is supported by the results of two open label, repeat dose, long-term Phase II studies (EV-004 and EV-006) and two Phase III randomized, multi-center, placebo-controlled, double blind trials (EV-001 and EV-002). In total, over 1,500 adult male and female subjects participated in the clinical program and the BLA was submitted within three years of the first subject's enrollment.
Murthy Simhambhatla, CEO of Evolus, said, "BLA acceptance for review marks a significant milestone achievement for the DWP-450 development program. We look forward to working with the FDA during the agency's review of the application."
Additional information about the studies can be found at www.clinicaltrials.gov, using clinical trial identifiers NCT02334423 (EV-001), NCT02334436 (EV-002), NCT02184988 (EV-004) and NCT02428608 (EV-006).
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 new 900 kDa Botulinum toxin Type A for the treatment of glabellar lines.