Astellas Pharma Inc. (TSE: 4503; President and CEO: Naoki Okamura) announced today its decision to withdraw the marketing authorization application for avacincaptad pegol intravitreal solution (ACP) from the European Medicines Agency (EMA). ACP is an investigational synthetic aptamer that inhibits the complement C5 protein and is intended for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The withdrawal comes after discussions with the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Astellas continues to assert that the clinically meaningful benefits of ACP in slowing GA lesion growth outweigh the associated risks. The company remains confident in ACP’s clinical profile and believes it offers significant advantages for patients living with GA.
Currently, there are no approved treatments for GA outside the U.S., but Astellas is fully committed to working with regulatory authorities to explore options for making ACP available to patients globally, including in Europe.
Marci English, Vice President and Head of BioPharma & Ophthalmology Development at Astellas, stated, “We want to highlight our confidence in ACP’s clinical profile, as shown in two randomized sham-controlled trials, and its potential to benefit those living with geographic atrophy (GA).
GA is a progressive and debilitating disease that leads to severe and irreversible vision loss and blindness. As our understanding of GA evolves, Astellas and other companies are at the forefront of developing new treatment options for affected individuals.
While we are disappointed by the CHMP’s response, we recognize the positive impact this medicine has had on GA patients in the U.S. and remain dedicated to addressing unmet patient needs worldwide.
