Regeneron's Eylea HD approved by FDA

The US Food and Drug Administration (FDA) approved Eylea HD (aflibercept) injection 8mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), Regeneron Pharmaceuticals (Nasdaq: REGN) disclosed after market closure, so validated management’s anticipation of manufacturing issue resolution.

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.

The recommended dose for EYLEA HD is 8mg (0.07 mL of 114.3 mg/mL solution) every four weeks (monthly) for the first three months across all indications, followed by 8mg every eight to 16 weeks in wAMD and DME and every eight to 12 weeks for DR.