Regeneron Pharmaceuticals, Inc.’s (REGN) highly successful eye drug is in the news again with the U.S. Food and Drug Administration (:FDA) accepting the company’s marketing application for another indication, macular edema following branch retinal vein occlusion (:BRVO). Shares showed a positive movement following the FDA’s move.
Regeneron had submitted the marketing application for BRVO – the fourth indication to be filed in the U.S. for Eylea – on the basis of encouraging data from a phase III study (:VIBRANT). The regulatory application for Eylea for the additional indication has been accepted for standard review by the U.S. regulatory body with a decision expected by Oct 23, 2014 (action date).
This is the second FDA action date on Eylea this year as Regeneron seeks to expand the drug’s label beyond the approved eye disorders -- neovascular (wet) age-related macular degeneration (AMD) and macular edema following central retinal vein occlusion (:CRVO). The FDA is expected to decide on Regeneron’s application seeking to market Eylea for the diabetic macular edema (:DME) indication by Aug 18, 2014.
Sales of the drug have been on the rise ever since its U.S. launch in late 2011 for the wet AMD indication. In Sep 2012, the FDA approved the label expansion of Eylea into the macular edema following CRVO indication.
Sales of Eylea in the U.S. climbed 46% in the fourth quarter of 2013 to $402 million. Regeneron expects Eylea to record 2014 U.S. sales in the range of $1.7–$1.8 billion, well above the $1.4 billion recorded in 2013. The guidance assumes that Eylea will be cleared in the U.S. for DME in the third quarter of this year.
We note that Eylea’s success is not limited to the U.S. The drug, which has been cleared in many ex-U.S. markets for the wet AMD and CRVO indications, came up with fourth quarter 2013 sales of $184 million (up 47% sequentially) in these markets as reported by partner Bayer (BAYRY). We believe investor focus will remain on updates regarding Eylea.
Regeneron, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Better-ranked biopharma stocks include Alexion Pharmaceuticals, Inc. (ALXN) and Gilead Sciences, Inc. (GILD). Both stocks carry a Zacks Rank #1 (Strong Buy).