Regeneron Pharmaceuticals has won Food and Drug Administration approval of extended dosing intervals of up to every 20 weeks for its Eylea HD eye drug.
Regeneron on Thursday said the extended dosing covers patients with wet age-related macular degeneration and diabetic macular edema following one year of successful response based on visual and anatomic outcomes.
The Tarrytown, N.Y., biotechnology company said the new dosing regimen allows patients to be treated as infrequently as two to three times a year, further extending the widest range of dosing intervals of any approved injectable anti-vascular endothelial growth factor, or anti-VEGF, therapy.
Eylea HD generated U.S. sales of nearly $1.64 billion last year.
Regeneron, which develops the Eylea franchise with Germany's Bayer, maintains exclusive rights to the products in the U.S., while Bayer has licensed the exclusive marketing rights outside the U.S., where the companies equally split profits from sales.
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