BAYRY - EMA panel backs approval of Regeneron Bayer's Eylea for eye disorder in infants

• A committee of the European Medicines Agency (EMA) recommended the expanded approval of Regeneron Pharmaceuticals ( NASDAQ: REGN ) and Bayer's ( OTCPK:BAYZF ) ( OTCPK:BAYRY ) Eylea to treat preterm infants with retinopathy of prematurity (ROP).
• ROP is an eye disease that can happen in some premature (born early) babies and can cause blindness.
• The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted new indication for Eylea to treat ROP with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease.
• Eylea is already approved in the EU to treat certain other types of eye diseases.
• Eylea is also under priority review in the U.S. to treat ROP in preterm infants.
• The European Commission, which generally follows the opinion of the CHMP, will now decide on the change to the terms of the marketing authorization of Eylea.
• Worldwide sales of Eylea grew +3.1% Y/Y to $2.45B in Q3.

For further details see: