(RTTNews) – Astellas Pharma Inc. (ALPMY, ALPMY) announced that the US Food and Drug Administration has approved a revised Supplemental Unique Drug Application, or sNDA, for ISERVAY (avacincaptad pegol intravitreal reply) for the treatment of age-related geographic atrophy (GA). -related macular degeneration (AMD) on January 6, 2025, primarily based on the agency’s November 2024 Complete Response Letter (CRL).
The Company is well aware that the device was refilled between the FDA and Astellas on December 20, 2024 and was designated as a Class 1 resubmission with a 60-day review.
The action date on the map was February 26, 2025.
ISERVAY was approved by the US Food and Drug Administration on August 4, 2023 for the treatment of geographic atrophy, which is a result of macular degeneration.
SNDA wants to be able to add certain 2-365-day records to the prescribing knowledge of ISERVAY US primarily based on the results of the Phase 3 GATHER2 clinical trial.
For more such health details talk to rttnews.com.
The views and opinions expressed herein are those of the author and developments do not necessarily reflect those of Nasdaq, Inc.
Leave a Reply