EMA accepts Iveric Bio’s avacincaptad pegol (ACP) for MAA review

Iveric Bio, a subsidiary of Astellas Pharma Inc., announced an update on the European status of its avacincaptad pegol (ACP) intravitreal solution for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The European Medicines Agency (EMA) has accepted the product’s marketing authorisation application (MAA) for regulatory review.¹ The announcement follows the product’s FDA approval in the US earlier this month.

In a news release, Iveric Bio described the product as an investigational complement C5 inhibitor for the treatment of GA secondary to AMD. The GATHER1 and GATHER2 Phase 3 clinical trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of ACP in patients with GA secondary to AMD. According to the company, primary analysis of each registrational trial showed a statistically significant reduction in the rate of GA growth in patients treated with ACP compared to sham.¹ Over 700 patients were evaluated in the two trials over a 12-month period.

Pravin U. Dugel, MD, president of Iveric Bio, called the acceptance of the MAA a “key milestone” in the ongoing global fight against GA, a leading cause of blindness. "We look forward to collaborating with CHMP throughout the review process and hope to make ACP available for patients in Europe,” Dugel said in a statement.

In the US, ACP was approved as IZERVAY™ on 4 August, 2023. The press release noted that acceptance of the MAA is not expected to have an impact on financial forecasts of the current fiscal year.

Reference

1. European Medicines Agency Accepts Iveric Bio's Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy. News release. Astellas Pharma Inc., August 18, 2023.