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Regeneron's Eylea Prefilled Syringe Clears FDA Hurdle

Shanthi Rexaline

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) shares were trading higher Tuesday after Eylea, its product to treat retinal conditions, snagged another approval.

What Happened

Regeneron said Tuesday ahead of the market open that the FDA approved the Chemistry, Manufacturing and Controls Prior Approval Supplement, or PAS, for the Eylea prefilled syringe.

Eylea, a vascular endothelial growth factor, is already approved four retinal conditions: neovascular wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.

The first approval came through in 2011.

Why It's Important

The 2mg, single-dose, sterilized prefilled syringe provides physicians with a new way to administer Eylea, requiring fewer preparatory steps compared to vials, Regeneron said.

"This approval may help doctors more conveniently and efficiently deliver EYLEA to appropriate patients," Chief Scientific Officer George Yancopoulos said in a statement. 

The company said the Eylea prefilled syringe is likely to be made available to physicians and patients this year.

Regeron shares were trading 2.57% higher to $303.47 at the time of publication Tuesday. 

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