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Astellas Faces FDA Setback on IZERVAY Application
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Astellas Faces FDA Setback on IZERVAY Application

Astellas Pharma (JP:4503) has released an update.

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Astellas Pharma received a Complete Response Letter from the FDA regarding its supplemental New Drug Application for IZERVAY, a treatment for geographic atrophy linked to age-related macular degeneration. The FDA’s concerns are not about the drug’s efficacy but rather a statistical issue with the proposed labeling. Astellas is working to address these comments and evaluate potential financial impacts.

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