By Colin Kellaher
Regeneron Pharmaceuticals Inc. on Wednesday said the U.S. Food and Drug Administration will review its application seeking approval of an extended dosing of its blockbuster eye treatment Eylea.
The Tarrytown, N.Y., biotechnology company said the application covers Eylea injection for every 16-week dosing in patients with diabetic retinopathy, the leading cause of blindness among working-age adults in the U.S.
Regeneron said the extended regimen, if approved, would provide a longer treatment interval and additional dosing flexibility for Eylea, which won FDA approval for four- and eight-week dosing regimens in 2019.
Regeneron, which reported U.S. Eylea sales of nearly $5.8 billion last year, said the FDA set a target action date of Feb. 28, 2023, for a decision on the 16-week regimen.
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(END) Dow Jones Newswires