A Phase 3 study to compare ABP-450 (prabotulinumtoxinA) with BOTOX® (onabotulinumtoxinA) as the reference product
Latest Information Update: 31 Mar 2025
At a glance
- Drugs Botulinum-Toxin-A (Primary)
- Indications Blepharospasm; Facial wrinkles; Gastroparesis; Glabellar lines; Hypertrophy; Migraine; Muscle spasticity; Post-traumatic stress disorders; Torticollis
- Focus Therapeutic Use
- 24 Mar 2025 According to an AEON Biopharma media release,the company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development.
- 24 Mar 2025 According to an AEON Biopharma media release, the company initiated the primary analytical studies in the fourth quarter of 2024 and plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development.
- 24 Mar 2025 Status changed from planning to recruiting, according to an AEON Biopharma media release.