The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP), an investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), Astellas Pharma (TYO: 4503) announced today.
ACP came to Astellas through its $5.9 billion recently completed acquisition of US biotech Iveric Bio, and marked the Japanese pharma major’s largest ever M&A deal. The drug gained US Food and Drug Administration (FDA) approval for the same indication earlier this month under the trade name Izervay.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will start its review of the MAA under the centralized licensing procedure for all 27 member states of the European Union (EU).
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