The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.
The FDA has pushed back its target decision date for two of Regeneron’s supplemental applications for a high-dose formulation of Eylea. After initially setting a decision date for Aug. 19, the agency now expects to deliver verdicts in the fourth quarter.
The delay applies to Regeneron’s application to use Eylea HD for patients with macular edema after retinal vein occlusion, as well as the proposal to expand its dosing schedule to include a monthly regimen across approved indications.
There do not appear to be problems with the safety or efficacy of Eylea HD in the affected applications. Instead, the review extension is linked to findings at a Catalent manufacturing site. Novo Nordisk, which acquired the CDMO giant in February last year, has already responded to the FDA’s observations, but the regulator considered the submission a major amendment to the affected applications.
“It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved,” Regeneron wrote on Wednesday. Meanwhile, Eylea HD vials will remain available in the U.S. for the already approved indications and dosing schedules.
Regeneron alluded to the delay earlier this month during second-quarter earnings on Aug. 1, revealing that the FDA would need to extend its review for the two Eylea HD applications. At the time, Novo hadn’t yet addressed the FDA’s concerns at the production facility, and Regeneron wasn’t able to provide an updated timeline for the decisions.
“Based on our discussions, we believe that there’s nothing significant left to be done,” CEO Leonard Schleifer said during an investor call at the time. “We are expecting, once the resolution of the filling issues has occurred, to receive favorable action, we hope, from the FDA.”
Despite an expected approval, the delays still represent a setback for Regeneron’s Eylea franchise, which once dominated the retinal disease market but has since steadily lost market share to Roche’s Vabysmo. Soon, Eylea will also have to contend with biosimilars after the FDA signed off on two interchangeable copycats in May 2024. One of these, Biocon Biologics’ Yesafili, is expected to hit U.S. shelves late next year. The U.S. launch for the other biosimilar, branded Opuviz and marketed by Samsung Bioepis and Biogen, is still uncertain.
Still, the updated FDA timeline likely puts the launch of the new Eylea versions ahead of investor expectations, BMO Capital Markets analysts noted on Wednesday.
“Given recent biosimilar competition and subsequent market erosion for Eylea, we appreciate a shorter path to regulatory approval as Regeneron attempts to regain market share for the franchise,” the firm wrote.
In the second quarter, the Eylea franchise suffered a 25% year-on-year sales dip, though its $1.15 billion in revenue still came 9% ahead of consensus forecasts.
