November 18, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
Regeneron Pharmaceuticals, Inc. announced Tuesday that Bayer HealthCare‘s Japanese subsidiary, Bayer Yakuhin, Ltd., has received approval from Japanese regulators for its injectable drug Eylea to treat patients with diabetic macular edema in that country.
The Japanese Ministry of Health, Labour and Welfare approved Eylea (aflibercept) for the separate indication of DME after previously giving it the green light to treat patients with neovascular age-related macular degeneration (wet AMD), macular edema secondary to central retinal vein occlusion (CRVO) and myopic choroidal neovascularization (myopic CNV).
Eylea works by blocking the growth of new blood vessels via an injection of vascular endothelial growth factor (VEGF) inhibitor. That then decreases the ability of fluid to pass into the eye by blocking VEGF-A and placental growth factor, primary components in angiogenesis. Preclinical studies have shown the drug also helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors.
Diabetic macular edema (DME) or often strikes the eyes of patients with diabetes, causing swelling of the macula and a loss of vision. Often, that loss turns to total blindness due to DME, a condition which Regeneron said affects around three percent of people with diabetes worldwide. It is the most frequent cause of blindness in young and middle aged adults in most developed countries.
Bayer HealthCare and Regeneron are collaborating on the global development of Eylea, with Tarrytown, NY-based Regeneron maintaining exclusive rights to the drug in the U.S.
Outside the U.S. the companies share sales profit equally, except for except for Japan, where Regeneron receives a percentage of net sales—which makes today’s news particularly notable for Regeneron.
American regulators have already approved the drug for wet AMD, DME and macular edema following retinal vein occlusion (RVO). Regeneron said in a statement that it has submitted a marketing authorization application to Japanese authorities to extend approval to treat RVO.
Thus far, Eylea has been approved to treat wet AMD in 80 countries, to treat visual impairment due to macular edema secondary to central retinal vein occlusion in 60, and to treat DME in over 30 countries.
