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Astellas Reports MAA Withdrawn for Avacincaptad Pegol (ACP) in the EU

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Astellas

Astellas Reports MAA Withdrawn for Avacincaptad Pegol (ACP) in the EU

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  • Astellas has withdrawn its MAA for Avacincaptad pegol intravitreal solution (ACP) for treating geographic atrophy (GA) related to age-related macular degeneration (AMD) in EU followed discussions with the EMA’s CHMP
  • Astellas appealing with regulatory authorities to explore options to bring ACP to GA patients globally (incl. EU) as company remains assured with clinical profile and capacity to slow GA lesions
  • Avacincaptad pegol, a complement C5 protein inhibitor was approved in the US as Izervay for the treatment of GA secondary to AMD. Astellas is evaluating the possible financial effects of withdrawn for the fiscal year ending March 31, 2025

Ref: Astellas | Image: Astellas

Related News:- Astellas Reports the US FDA’s Approval of Vyloy (Zolbetuximab-clzb) to Treat Advanced G/GEJ Cancer

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Dipanshu Dixit

A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com

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