Bayer gains new Eylea indication in Europe

Following a positive recommendation last month from the European Medicines Agency’s Medicinal Products for Human Use (CHMP; The Pharma Letter July 29), German drug major Bayer (BAYN: DE) says that Eylea (aflibercept solution for injection) has now received final approval from the European Commission for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).

Eylea, a direct competitor to Novartis’ Lucentis (ranibizumab; which is marketed in the USA by Roche), is already approved in the USA for the treatment of neovascular (wet) age-related macular degeneration (AMD) and for macular edema following CRVO. The drug has also been approved in Europe, Japan, Australia and several other countries for use in wet-AMD and in selected countries in South America for macular edema following CRVO.

Backed by encouraging Ph III studies