The US Food and Drug Administration (FDA) acceptance for standard review of Regeneron Pharmaceuticals' supplemental Biologics License Application (sBLA) for Eylea (aflibercept) injection for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, for a target action date of October 23, 2014.
"We are pleased that the FDA has accepted the sBLA for Eylea for the treatment of macular edema following BRVO, an important cause of vision loss," said George D Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories. "This is the fourth regulatory submission in the US for Eylea and, if approved, we hope it will provide a new treatment option for patients with macular edema following BRVO."
The Eylea sBLA submission in this indication is based on the positive results from the phase III VIBRANT trial, which was a double-masked, randomized, active-controlled study of 183 patients with Macular Edema following Branch Retinal Vein Occlusion. Patients received either intravitreal Eylea 2 milligrams (mg) every four weeks or laser treatment for 24 weeks. The primary objective of the study was to evaluate the efficacy and safety of Eylea in improving best-corrected visual acuity compared to laser treatment at week 24. The study is ongoing through week 52.
Eylea was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. Eylea has also been approved in the European Union (EU) and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have also been made in the US and the EU for Eylea for the treatment of Diabetic Macular Edema.
Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. However, in certain diseases, such as wet age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results.
Eylea, known in the scientific literature as VEGF Trap-Eye, is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Eylea acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.
Regeneron is collaborating with Bayer HealthCare on the global development of Eylea. Eylea is currently approved for the treatment of wet AMD in approximately 50 countries outside the US, including Japan and Australia and countries in the EU. Eylea has also been approved by the European Commission and in Japan for the treatment of visual impairment due to Macular Edema secondary to CRVO.
Regeneron maintains exclusive rights to Eylea in the United States.
Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.