Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura) has announced the withdrawal of its marketing authorization application from the European Medicines Agency (EMA) for avacincaptad pegol intravitreal solution (ACP). This investigational synthetic aptamer is designed to inhibit the complement C5 protein and was being considered for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The decision to withdraw follows recent discussions with the EMA’s Committee for Medicinal Products for Human Use (CHMP). Despite this, Astellas asserts that ACP provides a clinically meaningful benefit in slowing the progression of GA lesions, outweighing associated risks. The company remains confident in ACP’s clinical potential and believes its ability to slow disease progression is a valuable option for those affected by GA.
Currently, ACP is approved only in the United States, and Astellas is committed to exploring further regulatory pathways to make ACP accessible to GA patients worldwide, including in Europe.
Marci English, Vice President, Head of BioPharma & Ophthalmology Development at Astellas, stated:
“We are confident in ACP’s clinical profile, as evidenced by two randomized sham-controlled trials, and its potential benefits for people with geographic atrophy (GA). GA is a devastating, progressive disease that can lead to severe, irreversible vision loss and blindness. With advancements in GA research, Astellas and others are pioneering new treatments to address this unmet need.
Although we are disappointed with the CHMP’s response, we have witnessed the positive impact of this treatment for GA patients in the U.S. and remain dedicated to meeting the needs of patients globally.”
