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Randomized Double Blind Phase 3 Study to Assess the Efficacy and Safety of BoNT/A-DP in the Treatment of Glabellar Lines in Comparison With Placebo Followed by an Open Label Extension Study

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Trial Profile

Randomized Double Blind Phase 3 Study to Assess the Efficacy and Safety of BoNT/A-DP in the Treatment of Glabellar Lines in Comparison With Placebo Followed by an Open Label Extension Study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2024

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At a glance

  • Drugs Letibotulinumtoxina (Primary)
  • Indications Facial wrinkles; Glabellar lines
  • Focus Registrational; Therapeutic Use
  • Acronyms BLESS II
  • Sponsors Croma Pharma
  • Most Recent Events

    • 04 Mar 2024 According to a Hugel media release, the company has received approval from United States (U.S.) Food and Drug Administration (FDA) for Letybo to treat moderate-to-severe glabellar (frown) lines in adults, based on results from three completed phase III trials.
    • 01 Sep 2023 According to a Hugel media release, the company has resubmitted the BLA for its botulinum toxin, Letybo (letibotulinumtoxinA) on August 31st (local time), for the indication of glabellar (frown) lines to the U.S. FDA after completing a review of the facility management and supplementary work in-line with the CRL requests received from the FDA. Marketing approval for Letybo is projected for the first quarter of 2024.
    • 25 Oct 2022 According to a Hugel media release, the company announced the acceptance of its Biologics License Application for letibotulinumtoxinA, by the U.S. Food and Drug Administration (FDA). The FDA considered the resubmission a Class 2 response and has assigned a April 6, 2023 action date per the Prescription Drug User Fee Act (PDUFA)
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