Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) from its subsidiary IVERIC bio for the review of avacincaptad pegol (ACP) to treat geographic atrophy (GA).
ACP is an investigational complement C5 inhibitor to treat GA secondary to age-related macular degeneration (AMD).
The EMA's Committee for Medicinal Products for Human Use (CHMP) will commence the evaluation of the MAA through the centralised licensing process for all 27 European Union member states.
The company has submitted the MAA based on data from the Phase III GATHER1 and GATHER2 clinical trials.
Both studies assessed the efficacy and safety of monthly 2mg intravitreal administration of ACP in GA patients.
The primary analysis demonstrated a significant statistical decrease in GA growth rate among patients who received ACP treatment compared to placebo, in each registration trial conducted over 12 months.
Safety was evaluated in more than 700 GA patients across both studies.
Iveric Bio president Pravin Dugel stated: “This acceptance of our EU marketing authorisation application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide.
“We look forward to collaborating with CHMP throughout the review process and hope to make ACP available for patients in Europe.”
In August 2023, the FDA approved ACP as IZERVAY (avacincaptad pegol intravitreal solution) to treat GA.
