Roche's Lucentis may now have a bigger jump on Eylea in diabetic retinopathy. The Swiss drugmaker's Genentech unit won the FDA's "breakthrough" designation for that indication on Monday. And Lucentis was already on the FDA's priority review track, with a decision date in February.
Germany's cost-effectiveness watchdog said Bayer eye drug Eylea doesn't perform any better than its Novartis rival, Lucentis, as a treatment for diabetic macular edema.
Fast-growing wet AMD blockbuster Eylea delivered a surprise Tuesday, failing to surpass analyst expectations with a showing that prompted maker Regeneron to lower full-year sales guidance for the first time in the drug's three-year history.
Here's something Regeneron isn't used to: Cutting sales forecasts for blockbuster eye drug Eylea. But that's just what the New York biotech did Tuesday amid lower-than-expected third-quarter results.
Regeneron and Bayer's Eylea has been racking up sales that have consistently topped analyst expectations since its U.S. rollout in late 2011. Now, new data may help it potentially top them in a market Novartis and Roche got to first.
The approvals, and the sales, just keep piling up for Eylea, the blockbuster that Bayer shares with developer Regeneron. Just weeks after getting an important nod in Europe, it has won approval in Japan, the world's third largest market, for use in myopic choroidal neovascularization.
Plenty of drugmakers are chasing opportunity in diabetes. The fast-growing epidemic means new therapies are sorely needed. But dealing with diabetes directly isn't the only strategy. Regeneron figures it can score by treating some of the disease's long-term complications.
The European Commission has approved Bayer's Eylea (aflibercept) for the treatment of diabetic macular edema, the most common cause of vision loss among people with diabetes.
After a brief hiatus, Regeneron is back to steamrolling analysts' expectations. Tuesday, the drugmaker reported second-quarter results that topped Wall Street's projections, thanks once again to growing demand for macular degeneration treatment Eylea.
Bayer's drug business has been on a roll, thanks to some serious growth in its 5 newest products, including the clot-fighter Xarelto and the PAH med Adempas.