EMA panel backs approval of Regeneron, Bayer's Eylea for eye disorder in infants
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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.