Regeneron, which was thinking its blockbuster eye drug Eylea would extend its market dominance with a new, more convenient 12-week dosing schedule for some patients, is having to think twice. The FDA has interrupted those plans with delivery of a CRL.
Regeneron today announced that the FDA has issued the complete response letter for the company's application for a 12-week dosing interval of Eylea for patients with wet age-related macular degeneration based on physicians' assessment. It currently is approved for dosing in eight-week intervals.
Regeneron didn’t provide any details on the reason for the CRL, saying only that it was tied to ongoing labeling discussions.
Showing confidence, the company said: “Regeneron expects to complete these discussions and receive a final FDA action within approximately two months.”
If the wrangling lasts longer than that, the Tarrytown, New York-based company faces the risk of running up against a new competitor from Novartis. The Swiss company has said it will submit its application late this year for RTH258, which it also expects to get approved with 12-week dosing. Meanwhile, Roche is seeking approval for extended dosing of competing eye drug Lucentis.
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Jefferies analysts in a note to investors today expressed surprise at the turn of events given that Regeneron’s European partner Bayer two weeks ago announced regulators approved an extension regimen for the drug. That was based on another study showing 57% of evaluated patients were successfully extended to 12-week intervals and some even to 16 weeks.
The interruption comes as Eyela has been outperforming expectations. In last week’s report, second-quarter sales of the drug climbed 26% to reach $415 million, solidly beating forecasts of $410 million. Despite the leap, Regeneron kept its full-year sales guidance for the med in place at $1.7 billion to $1.8 billion.
Regeneron also hopes to offset Eylea competition with a slew of new meds developed with Sanofi, including alirocumab, a cholesterol-fighter with blockbuster potential.