Biotech Stock News: Regeneron’s Eylea Gets An Important Approval From FDA

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Good news flowed in at Regeneron Pharmaceuticals (REGN) when the FDA cleared the company’s highly successful injectable eye drug for macular edema following retinal vein occlusion (RVO), a common retinal vascular disorder. Approval for the broad RVO indication includes sub-indications like, macular edema following branch retinal vein occlusion (BRVO) and macular edema following central retinal vein occlusion (CRVO).

We remind investors that Eylea is already available in the U.S. for treating patients suffering from macular edema following CRVO. The FDA approval for the CRVO indication was gained in Sep 2012.

Approval for treating macular edema following RVO was facilitated by the fact that Eylea has already been cleared for the CRVO indication. Moreover, encouraging data from the phase III VIBRANT study (n=181), which evaluated Eylea in the BRVO indication, also formed the basis of the FDA approval.

We note that FDA clearance for the RVO indication is the second one for which Eylea has been approved this year in the U.S. In July this year, the FDA cleared Eylea for treatment of patients suffering from diabetic macular edema.

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The first indication, for which Eylea gained approval in the U.S., was wet age-related macular degeneration (AMD). Ever since its launch for the wet AMD indication in the U.S. in late 2011, Eylea has performed well. Approval for the new indication – RVO – will boost the drug’s sales potential further. It will also go a long way in helping the drug meet the company’s 2014 Eylea U.S. sales guidance of $1.7 billion to $1.8 billion.

Notably, Regeneron holds exclusive rights to sell Eylea within the U.S. The healthcare segment of Bayer (BAYRY) has licensed exclusive commercialization rights for the product in the ex-U.S. markets. Regeneron and Bayer equally share the profits from Eylea sales in all ex-U.S. territories except Japan, where Regeneron receives royalties on Eylea’s net sales.

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Eylea is already available in many ex-U.S. markets including the EU for the wet AMD, macular edema following CRVO and DME indications. Approval for the macular edema following BRVO indication has been sought in many ex-U.S. markets.

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