Astellas Withdraws EU Application for Geographic Atrophy Drug Avacincaptad Pegol

Key Insights

• Astellas Pharma has withdrawn its marketing application to the European Medicines Agency (EMA) for avacincaptad pegol, a treatment for geographic atrophy secondary to age-related macular degeneration.
• The decision was influenced by interactions with the EMA, despite positive clinical trial results observed in the United States.
• Astellas remains confident in avacincaptad pegol's clinical benefits and is committed to pursuing regulatory approvals globally.

Astellas Pharma has announced the withdrawal of its marketing authorization application for avacincaptad pegol in the European Union. The drug is intended for the treatment of geographic atrophy (GA) associated with age-related macular degeneration (AMD). Despite demonstrating positive results in clinical trials conducted in the United States, Astellas cited ongoing interactions with the European Medicines Agency (EMA) as the primary reason for this decision.

Avacincaptad pegol is a novel investigational complement C5 inhibitor designed to target the underlying mechanisms driving GA progression. GA, a leading cause of irreversible vision loss, affects millions worldwide. The current treatment landscape for GA is limited, highlighting a significant unmet medical need.

While the company did not disclose specific details regarding the EMA's concerns, Astellas emphasized its continued belief in the clinical benefits of avacincaptad pegol. The company reaffirmed its commitment to working with regulatory agencies globally to explore potential pathways for bringing this therapy to patients. Further details regarding Astellas's global regulatory strategy for avacincaptad pegol were not disclosed in the announcement.