Iveric Bio’s marketing authorisation application for avacincaptad pegol accepted by EMA
Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for avacincaptad pegol (ACP) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
It is expected that the Committee for Medicinal Products for Human Use (CHMP) will review the MAA under the centralised licensing procedure of all 27 member states of the EU.
This MAA was based on results from the GATHER1 and GATHER2 phase 3 clinical trials, both of which assessed the safety and efficacy of monthly 2mg intravitreal administration of ACP in patients with GA secondary to AMD. The drug showed a statistically significant reduction in the rate of GA growth, compared to placebo.
The drug is already approved by the US Food and Drug Administration as Izervay for this indication.
Pravin U Dugel MD, president of Iveric Bio, an Astellas company, commented: “This acceptance of our EU MAA 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.”
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