The FDA approved Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) approved Eylea HD (aflibercept) Injection 8 mg for wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR).
In June, the FDA issued a Complete Response Letter for Regeneron’s aflibercept 8 mg Biologics License application due to an ongoing review of inspection findings at a third-party filler.
The recommended dose for Eylea HD is 8 mg (0.07 mL of 114.3 mg/mL solution) every four weeks (monthly) for the first three months across all indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) in wAMD and DME and every 8 to 12 weeks (2 to 3 months) for DR.
The FDA approval is based on the 48-week results of PULSAR and PHOTON – two pivotal trials evaluating Eylea HD compared to Eylea (aflibercept) Injection 2 mg.
Both the PULSAR trial in wAMD (N=1,009) and PHOTON trial in DME (N=658) met their primary endpoint, with Eylea HD demonstrating non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only three initial monthly doses, compared to an Eylea 8-week dosing regimen after initial monthly doses.
Regeneron and Bayer AG (OTC:BAYRY) (OTC:BAYZF) are jointly developing Eylea HD.
Eylea HD is priced at $2,625 per single-use vial in the U.S.
Price Action: REGN shares closed at $812.40 on Friday.
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