Regeneron's Eylea Approved by Japanese Regulator
Nov 22nd 2013 9:29PM
Updated Nov 22nd 2013 9:30PM
Regeneron will soon have a bigger presence on the Asian market. The company announced that its Eylea medication has been granted approval for the treatment of macular edema following central retinal vein occlusion (CRVO), from Japan's Ministry of Health, Labor, and Welfare.
It is the latest in a series of approvals for the medication, which has already been cleared in Japan, the U.S., the European Union, and several other markets for the treatment of neovascular, or wet age-related macular degeneration. Regulatory submissions have also been filed in the U.S. and the EU for Eylea to treat diabetic macular edema.
CRVO is the backing up of blood and fluid in the retina of the eye, caused by obstruction of the central retinal vein. It can cause damage to the retina and loss of vision. The worldwide market for it numbers in the hundreds of thousands of individuals -- according to Regeneron's figures, around 100,000 people over the age of 40 in the U.S., 140,000 in Japan, and 66,000 in "major" European nations are afflicted with the disorder.
The company is developing Eylea on a global basis with Germany's Bayer HealthCare, although it maintains exclusive rights to the treatment in the U.S.
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