Eylea gets yet another approval, this one in Japan

The approvals, and the sales, just keep piling up for Eylea, the blockbuster that Bayer shares with developer Regeneron ($REGN). Just weeks after getting an important nod in Europe, it has won approval in Japan, the world's third largest market, for use in myopic choroidal neovascularization (myopic CNV).

Bayer announced Monday that the approval by Japan's Ministry of Health, Labour and Welfare was based on positive data from the Phase III MYRROR study in myopic CNV in which patients' vision improved markedly in 24 weeks.

The drugmaker said that in Japan, pathologic myopia and the associated myopic CNV is the second most common cause of blindness. "Myopic CNV has a poor prognosis and more treatment options are needed to address the urgent medical need for these patients, many of whom are of working age," Dr. Joerg Moeller, Bayer's head of global development, said in a statement. "A treatment option that could not only prevent permanent vision loss but could also improve visual acuity would have great benefits for patients with pathologic myopia."

Already blowing past analysts' quarterly forecasts, Eylea keeps getting new approvals that will only add to its sales. In August, Bayer won European approval for the treatment of diabetic macular edema (DME), the most common cause of vision loss among people with diabetes. That came after the FDA approved the drug for the same condition in July. It is behind its main competition in that treatment area. Lucentis, sold by Roche ($RHHBY) and Novartis ($NVS), has been approved for DME in Europe since 2011 and the U.S. since 2012.

But just a week ago the FDA granted Eylea its coveted "breakthrough therapy" designation for treatment of diabetic retinopathy, which opens it up to a quick appraisal process. There are currently no drugs approved for the condition and it is a large and so potentially very lucrative market. The company has said an estimated 7.7 million people in the U.S. have diabetic retinopathy, compared to about 2.5 million that have DME.

Approved in November 2011, in the second quarter Eylea again topped analyst estimates with sales of $415 million, up 26%. Regeneron sells the drug in the U.S., while Bayer sells it outside of the U.S. They share profits equally in those markets, except Japan, where Regeneron gets a royalty on net sales.

- here's the release

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