Astellas Pharma has announced the withdrawal of its marketing authorisation application for avacincaptad pegol intravitreal solution (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) from the European Medicines Agency (EMA).
The withdrawal follows discussions with the EMA’s Committee for Medicinal Products for Human Use (CHMP).
AMD is a significant cause of central vision loss in the elderly, often affecting both eyes.
ACP, an investigational synthetic aptamer, inhibits the complement C5 protein.
The overactivity of the complement system and C5 protein contributes to the scarring and vision loss associated with GA secondary to AMD.
By acting on C5, ACP reduces the activity of the complement system, which is implicated in the degeneration of retinal cells, potentially slowing the progression of GA.
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Astellas ophthalmology development vice-president and head Marci English stated: “We would like to emphasise our confidence in ACP’s clinical profile as demonstrated in two randomised sham-controlled trials and its potential to benefit people living with geographic atrophy (GA).
“While we are disappointed with the CHMP’s response, we have seen the impact this medicine has had for GA patients in the US and remain committed to serving unmet patient needs globally.”
Astellas is examining the possible financial effects of this issue for the fiscal year ending 31 March 2025.
Despite the withdrawal, Astellas maintains a positive stance on ACP. The company continues to have confidence in ACP’s clinical profile and its potential to slow the disease.
There are no currently approved treatments for GA secondary to AMD outside the US, where ACP was approved under the name IZERVAY in August 2023.
Astellas will work with regulatory authorities to explore all available options to make ACP accessible to patients with GA globally, including those in Europe.
Astellas recently received US Food and Drug Administration approval for VYLOY (zolbetuximab-clzb), in conjunction with chemotherapy, for the treatment of advanced gastric and gastroesophageal junction cancer.
