IQWIG says Eylea has 'no additional benefit'

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said in a preliminary benefit assessment that Eylea aflibercept from Bayer AG (Xetra:BAYN) has "no additional benefit" over Lucentis ranibizumab, the comparator requested by Germany's Federal Joint Committee (G-BA) to treat wet age-related macular degeneration (AMD). The institute said the data Bayer submitted comparing Eylea and Lucentis were "not suitable" because Lucentis was not administered according to its European label. In the Phase III VIEW1 and VIEW2 trials, patients in the Lucentis arm continued to receive the drug regardless of whether they had reached maximum visual acuity. Lucentis' European label notes that it is to be given monthly until a patient reaches maximum visual acuity, defined as three consecutive months of stable visual acuity.

Bayer said it will respond to the assessment by the April 5 deadline. A final assessment from G-BA is expected in early June. Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) has rights to Eylea in the U.S., while Bayer has rights to market the human fusion protein that binds all forms of VEGF-A and placental growth factor (PIGF) elsewhere. Regeneron was off $0.09 to $171.84 on Friday. ...