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In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 
• By Sushmita Panda

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

• Source: Shutterstock

Regeneron Pharmaceuticals’ attempts to extend the dosing interval for its eye drug, Eylea HD (aflibercept) injection 8mg, have hit a setback, but not one that is likely to hamper the product’s sales to any great extent. More rests on further approval decisions to come as the company hopes to stave off biosimilar competition and that from Roche’s newer rival, Vabysmo.

The US Food and Drug Administration rejected the company’s proposal to add additional extended dosing intervals of up to every...

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