Astellas Withdraws European Application for Avacincaptad Pegol in Geographic Atrophy
核心洞察
Astellas has withdrawn its marketing authorization application for avacincaptad pegol (ACP) in Europe for treating geographic atrophy (搜索) (GA) secondary to age-related macular degeneration (搜索) (AMD).
The decision follows discussions with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
Astellas remains confident in ACP's clinical profile, citing positive results from randomized, sham-controlled trials and its approval in the US under the name IZERVAY.
Astellas Pharma has announced the withdrawal of its marketing authorization application for avacincaptad pegol intravitreal solution (ACP) from the European Medicines Agency (EMA). The application sought approval for ACP in treating geographic atrophy (搜索) (GA) secondary to age-related macular degeneration (搜索) (AMD). This decision was made following discussions with the EMA’s Committee for Medicinal Products for Human Use (CHMP).
AMD is a leading cause of central vision loss in the elderly, often affecting both eyes. The overactivity of the complement system and C5 protein contributes to the scarring and vision loss associated with GA secondary to AMD. ACP, an investigational synthetic aptamer, functions by inhibiting the complement C5 protein (搜索), reducing the activity of the complement system implicated in the degeneration of retinal cells, potentially slowing the progression of GA.
Company's Stance and Future Plans
Despite the withdrawal, Astellas maintains a positive outlook on ACP. Marci English, Astellas ophthalmology development vice-president and head, emphasized the company's confidence in ACP’s clinical profile, as demonstrated in two randomized sham-controlled trials. She highlighted the impact of the medicine for GA patients in the US, where it was approved under the name IZERVAY in August 2023, and reiterated the commitment to serving unmet patient needs globally.
Astellas is currently assessing the potential financial implications of this withdrawal for the fiscal year ending March 31, 2025. The company is committed to working with regulatory authorities to explore all available options to make ACP accessible to patients with GA globally, including those in Europe, where there are currently no approved treatments for GA secondary to AMD outside the US.
Avacincaptad Pegol (ACP) and Geographic Atrophy (GA)
Avacincaptad pegol is designed to target and inhibit the complement C5 protein (搜索). By acting on C5, ACP aims to modulate the complement system, which is implicated in the degeneration of retinal cells, potentially slowing the progression of GA. The rationale behind ACP is rooted in the understanding that overactivity of the complement system and C5 protein contributes to the scarring and vision loss associated with GA secondary to AMD.
Broader Portfolio
In other news, Astellas recently received US Food and Drug Administration approval for VYLOY (zolbetuximab-clzb (搜索)), in conjunction with chemotherapy, for the treatment of advanced gastric and gastroesophageal junction cancer.