FDA to Review Eylea Injection

Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of Eylea (aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. The target action date for the FDA decision is May 13, 2019.

The sBLA submission is based on results from the Phase 3 PANORAMA trial investigating EYLEA as a treatment for patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). Positive six-month topline results from PANORAMA were announced in March 2018. One-year results from PANORAMA are expected to be shared later this year.

The safety and efficacy of the potential use of Eylea in DR without DME has not been fully evaluated by any regulatory authority.

Eylea is administered as a 2 mg intravitreal injection and currently indicated to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, DME, and DR in patients with DME.

Approximately eight million people live with DR, a disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease generally starts as NPDR and often has no warning signs or symptoms. NPDR may progress to proliferative diabetic retinopathy (PDR), a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and potentially cause severe, vision-threatening complications such as vitreous hemorrhage and traction retinal detachment.

DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the U.S., approximately 1.5 million adults are diagnosed with DME, while approximately 3.5 million people suffer from DR without DME.

Eylea (aflibercept) Injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In the U.S., Eylea is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes seven pivotal Phase 3 trials.

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