Bayer said earlier this week that it would be counting on eye blockbuster Eylea to provide some serious sales growth in 2015, and now, it has a new indication the company hopes can help it get there.
Bayer has won an approval from England's National Institute for Health and Care Excellence (NICE) for its popular eye drug Eylea. But it was a mixed result. The drugmaker offered a discount to get the approval and then NICE granted it for some, but not all, patients with diabetic macular edema.
Regeneron's eye drug Eylea picked up steam against two competing products from Roche, as the first head-to-head study comparing the meds found that Eylea outperformed Lucentis and Avastin in treating moderate to severe vision loss in patients with diabetic macular edema.
Roche now has another approval under its belt for eye drug Lucentis. And it's in a market it can call its own: Lucentis is the first U.S.-approved treatment for diabetic retinopathy in patients with diabetic macular edema.
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.