Regeneron's Extended Eylea Dosing Plan Suffers US FDA Delay
Competitors are moving forward on wet AMD products with longer dosing intervals, with Novartis close to filing with FDA.
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Allergan and Molecular Partners said dosing of the VEGF inhibitor every eight or 12 weeks was non-inferior to Lucentis every four weeks. But while AMD patients would enjoy fewer sharp pokes in the eye, about 15% may experience inflammation – at least until a new formulation is available.
Hudson has gained his footing running Novartis' pharma business. Now, he's preparing to launch seven new drugs by 2020 while growing Cosentyx, Entresto and other in-line products.
Novartis says nAMD eye treatment brolucizumab showed further advantages over Eylea in two Phase III studies, reinforcing plans to file in late 2018 for a commercial launch in 2019.