FDA does not approve additional extended dosing intervals for Eylea HD
Key takeaways:
- The FDA did not approve the supplemental biologics license application for Eylea HD.
- The application would have added extended dosing intervals greater than 16 weeks, if approved.
Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA issued a complete response letter for a supplemental biologics license application, in which it did not approve extending the dosing intervals for Eylea HD, according to a press release from Regeneron.
Eylea HD (aflibercept injection 8 mg) is currently approved for dosing intervals of every 8 to 16 weeks to treat wet age-related macular degeneration and diabetic macular edema, as well as every 8 to 12 weeks to treat diabetic retinopathy, after three initial monthly doses. If approved, the supplemental biologics license application would have added extended dosing intervals of up to every 24 weeks.
“Regeneron is evaluating the FDA’s decision and will determine a path forward in due course,” the company said in the release.
The complete response letter identified no safety or efficacy issues with Eylea HD.
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