Astellas : EMA Accepts Iveric Bio's MAA For Avacincaptad Pegol For Geographic Atrophy

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) said the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application or MAA for avacincaptad pegol, an investigational complement C5 inhibitor for the treatment of geographic atrophy secondary to age-related macular degeneration or AMD.

The company noted that the Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized licensing procedure for all 27 member states of the European Union (EU).

Geographic atrophy is a form of age-related macular degeneration that can cause irreversible vision loss. Without timely treatment, an estimated 66% of people with Geographic atrophy may become blind or severely visually impaired.

Avacincaptad pegol was approved by the U.S. Food and Drug Administration as IZERVAY for the treatment of geographic atrophy secondary to age-related macular degeneration on August 4, 2023.