Regeneron Pharmaceuticals (REGN) said late Friday that the US Food and Drug Administration issued a complete response letter rejecting its request to add extended dosing intervals for Eylea HD injection 8 mg across all approved indications.
The company said the health agency raised no concerns about the drug's safety or efficacy but declined to approve the extended schedule.
The drugmaker said it is reviewing the decision and considering the next steps.
Eylea HD is approved to treat wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
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