Regeneron announced that the FDA issued a complete response letter rejecting the company’s request to extend dosing intervals for Eylea HD (aflibercept 8 mg) to up to 24 weeks. The letter did not raise concerns about the drug’s safety or efficacy in its approved uses. However, the FDA did not support extending dosing beyond the current maximum of every 16 weeks.
Eylea HD is currently approved for:
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Wet AMD and DME: every 8 to 16 weeks after 3 monthly doses
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Diabetic retinopathy: every 8 to 12 weeks after 3 monthly doses
Regeneron is reviewing the FDA’s feedback to determine next steps.
Read the full press release here.
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