Astellas Withdraws European Application for Geographic Atrophy Treatment Izervay

Withdrawal of Application:
Astellas Pharma has withdrawn its marketing authorization application for avacincaptad pegol (Izervay) from the European Medicines Agency, citing disagreements with European regulators over the drug's approval for treating geographic atrophy secondary to age-related macular degeneration.

Background:
Izervay, developed by Iveric Bio and acquired by Astellas, received FDA approval in August 2023 for treating geographic atrophy in the United States.

Commercial Opportunity:
Despite the withdrawal in Europe, Izervay presents a significant commercial opportunity for Astellas in the U.S. market, particularly given the side effects associated with its competitor, Apellis' Syfovre.

Market Impact:
The withdrawal in Europe may impact Astellas' global sales projections for Izervay, but the drug still holds potential for substantial revenue in the U.S. market.

Regulatory Disagreement:
The withdrawal highlights the challenges pharmaceutical companies face in navigating different regulatory environments across regions, with Astellas unable to align with European regulatory expectations for Izervay.