Astellas Withdraws European Application for Avacincaptad Pegol for GA

Astellas Pharma announced it is withdrawing its marketing authorization application for avacincaptad pegol (ACP) from the European Medicines Agency (EMA). ACP, an investigational intravitreal treatment designed to inhibit the complement C5 protein, was developed for geographic atrophy (GA) associated with age-related macular degeneration (AMD).

Although Astellas expressed confidence in ACP's clinical effectiveness and its potential benefit for patients with GA, the company decided to withdraw its application following discussions with the EMA’s Committee for Medicinal Products for Human Use (CHMP).

“We would like to emphasize our confidence in ACP’s clinical profile as demonstrated in two randomized sham-controlled trials and its potential to benefit people living with geographic atrophy (GA),” Marci English, Vice President and Head of BioPharma & Ophthalmology Development at Astellas, said in a company news release. “GA is a devastating progressive disease, which leads to severe and irreversible visual impairment and blindness. While we are disappointed with the CHMP's response, we have seen the impact this medicine has had for GA patients in the U.S. and remain committed to serving unmet patient needs globally.”

In August 2023, Iveric Bio received FDA approval for Izervay (avacincaptad pegol intravitreal solution) for the treatment of GA secondary to age-related macular degeneration (AMD). It was the second GA treatment approved by the FDA and the only approved GA treatment with a statistically significant reduction (P<0.01) in the rate of GA progression at the 12-month primary endpoint across two phase 3 clinical trials parent company.

Japan-based Astellas Pharma acquired Iveric Bio in May 2023 for $5.9 billion. Iveric Bio became a indirectly wholly-owned subsidiary of Astellas.

Astellas said it remains commited to working with regulatory agencies in Europe and other regions to explore ways to make ACP accessible to GA patients worldwide.

The company said it is evaluating the potential financial implications of this decision on its fiscal year ending March 31, 2025.