US FDA approves higher dose of Regeneron's eye disease drug Eylea

[August 19, 2023]  By Jahnavi Nidumolu

(Reuters) -The U.S. Food and Drug Administration approved a higher dose version of Regeneron Pharmaceuticals' drug Eylea for treatment of a disease that is a leading cause of blindness among the elderly, the company said in a statement on Friday.

The drug, Eylea HD, is priced at $2,625 per single-use vial in the U.S. and is used to treat patients with wet age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy (DR), Regeneron said.

Eylea, which is jointly developed with Bayer, is normally given in doses of 2 milligrams every eight weeks. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 mg at longer intervals without any additional safety issues.

In June, the FDA declined to approve the higher dose version of Eylea and said it had outstanding questions, citing an ongoing review of inspection at third-party manufacturer Catalent .

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Earlier in the day, the FDA approved another Regeneron drug, branded as Veopoz to treat a rare blood disease CHAPLE.

With Veopoz's approval, the company said earlier that the pre-approval inspection issues related to the marketing application of Eylea HD, or aflibercept, has been addressed.

An estimated 1.4 million people in the U.S. have wet AMD, according to Regeneron.

(Reporting by Jahnavi Nidumolu in Bengaluru; Editing by Sandra Maler, Rosalba O'Brien and Diane Craft)

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