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Regeneron's Less Frequent Eylea Dosing Makes Late Sprint Across FDA Finish Line

 
• By Mandy Jackson

Regeneron's blockbuster AMD biologic Eylea improved its ability to compete with future longer-acting VEGF inhibitors with a label supporting every dosing every 12 weeks; the company's less frequent regimen cleared FDA five days after receiving a complete response letter.

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.

US FDA’s Aug. 17 approval of a supplemental biologic license application for Eylea (aflibercept) keeps Regeneron Pharmaceuticals Inc. well ahead of competitors developing treatments for wet age-related macular degeneration (AMD) that can be given less often, a significant advantage for products that are injected into the eye.

The sBLA for Eylea dosed every 12 weeks was approved just four days after the company said it received a...

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