Astellas Provides Update on Marketing Authorization Application for Avacincaptad Pegol (ACP) in the European Union

Astellas Pharma Inc. announced the company’s decision to withdraw its marketing authorization application from the European Medicines Agency (EMA) for avacincaptad pegol intravitreal solution (ACP), an investigational synthetic aptamer that inhibits the complement C5 protein, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The company’s decision to withdraw its application followed interactions with the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Astellas maintains that the clinically meaningful benefit of ACP in slowing GA lesion growth outweighs the risks. Astellas remains confident in ACP’s clinical profile and believes its capacity to slow disease is a benefit for people living with GA.

There are currently no approved treatments outside of the U.S. Astellas is fully committed to engaging with regulatory authorities to explore available options to bring ACP to patients with GA globally (including in Europe).

Marci English, Vice President, Head of BioPharma & Ophthalmology Development, Astellas
“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).

GA is a devastating progressive disease, which leads to severe and irreversible visual impairment and blindness. As the science and understanding of GA expands, Astellas and other companies are pioneering the way to bring new treatment options to people with the disease.

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.”

Astellas is reviewing the potential financial impact of this matter for the fiscal year ending March 31, 2025.