Source: PR Newswire
ALPHAEON Corporation (www.alphaeon.com) today announced that its wholly-owned subsidiary, Evolus Inc., submitted a Biologics License Application (BLA) for DWP-450, a Botulinum toxin Type A, to the U.S. Food and Drug Administration (FDA) seeking approval for the treatment of adult patients with glabellar lines, also known as “frown lines” between the eyebrows.
The BLA submission is based on 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.
Chris Marmo, President of Beauty for ALPHAEON, said, “Submission of the BLA within three years of the first study enrollment speaks to the experience, drive and commitment of the Evolus team. We are excited to move one step closer to commercial launch of the product.”
Murthy Simhambhatla, CEO of ALPHAEON, said, “The BLA Submission 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).