Regeneron Pharmaceuticals Inc said the Japanese Ministry of Health, Labor and Welfare gave its approval to EYLEA (aflibercept) Injection for the treatment macular edema following Central Retinal Vein Occlusion or CRVO. The therapy was first approved by US regulators in November 2011 to treat neovascular (wet) Age-related Macular Degeneration or AMD. The US approval for EYLEA to be used as treatment for macular edema following CRVO came in September last year.
The EU and some countries in Asia and Latin America have also given its approval for the therapy to be used for visual impairment caused by macular edema following CRVO. The company has also filed regulatory applications in the EU and the US to have the therapy approved for the treatment of diabetic macular edema.
Chief Scientific Officer of Regeneron and President of Regeneron Laboratories George D. Yancopoulos, MD, PhD said in a statement that he is pleased with the approval given by the Japanese regulator. He added, "This approval reflects our commitment, along with our partner Bayer HealthCare, to bring EYLEA to patients worldwide."
The approval will also give Regeneron a larger presence in the Asian market, according to a report in The Motley Fool. Developed together with Bayer HealthCare, Regeneron will continue to have exclusive rights to EYLEA in the US. Bayer HealthCare, however, have license to the exclusive marketing rights outside the US where both firms will share profits of EYLEA sales equally. In Japan, however, Regeneron will get a royalty on the drug's net sales.
The obstruction of the central retinal vein which leads blood and fluid to back up in the retina is the cause of CRVO. Damage to the retina and consequent loss of vision ultimately results.
In its latest earnings report, Regeneron said US net product sales of EYLEA increased 49% to USD 363 million in the third quarter compared to the USD 244 million it posted in the same period last year.
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