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Regeneron Raises Possibility Of Quick CRL Resolution For High-Dose Eylea

 
• By Joseph Haas

On its Q2 earnings call, Regeneron said its 8mg formulation of aflibercept could obtain US FDA approval this quarter, despite receiving a complete response letter in June. Refiling’s fate tied to review of pozelimab.

Regeneron
Regeneron now expects high-dose Eylea to gain approval this quarter • Source: Shutterstock: lev radin

Regeneron Pharmaceuticals, Inc. gave investors some unexpected potential good news during its second quarter sales and earnings call on 3 August, saying that its US filing of high-dose Eylea may obtain approval during the current quarter, perhaps even before the end of August, following a US Food and Drug Administration complete response letter on 27 June.

Eylea (aflibercept), an anti-VEGF agent, is approved for dosing every eight weeks at 2mg and has become the standard of...

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