(RTTNews) - Wednesday, AEON Biopharma (AEON) said FDA feedback from a Type 2b meeting provided clarity on the development pathway for ABP-450 as a biosimilar to BOTOX. ABP-450 is a botulinum toxin being developed for therapeutic indications. AEON plans to submit an IND for a comparative pharmacodynamic study using Compound Muscle Action Potential (CMAP) measurements in the fourth quarter of 2026. The FDA indicated that previously completed comparative studies of ABP-450 versus BOTOX could be submitted as supportive evidence, subject to scientific bridging.
Главную мысль мы показываем публично. Создайте бесплатный аккаунт, чтобы читать статью полностью, сохранять ее, обсуждать и связывать с рынками и OSINT-контекстом.