Even as Regeneron’s superstar Eylea inches toward the end of its run as the world's top eye medicine, the drug just scored a key exclusivity extension from the FDA.
Friday, Regeneron said the FDA has granted a 6-month pediatric exclusivity extension to Eylea. The agency made the decision based on data from two trials evaluating the drug in preterm infants.
With the FDA decision, Eylea will retain regulatory exclusivity in the U.S. until May 17, 2024, Regeneron said. Previously, the regulatory protection was set to lapse in November 2023.
This could be a very lucrative development for Regeneron. Since the drug generated $5.8 billion in the U.S. last year, an extra six months of market exclusivity could be worth billions of dollars.
Meanwhile, Eylea's patents begin to expire next year and run into the next decade, according to Regeneron's latest annual filing with the SEC. It isn't immediately clear which patents would preclude a biosimilar launch, but the key "composition of matter" patent runs out next June.
Companies such as Alvotech, Novartis' Sandoz and Samsung Bioepis are working on biosimilar versions of Eylea, according to reports. But even before they launch, Eylea is already facing competition from Roche's new Vabysmo and its older Lucentis, which already faces U.S. copycats.
Eylea won its original FDA approval in 2011 and carries FDA nods to treat wet age-related macular degeneration, diabetic retinopathy, diabetic macular edema and macular edema following retinal vein occlusion.
The pediatric exclusivity extension comes as a result of studies in retinopathy of prematurity (ROP) in preterm infants. The FDA previously requested Regeneron research the potential use, and the company has subsequently submitted data from two phase 3 studies to the regulator.
That application has a priority review and is set for a February 2023 decision by the FDA.
ROP often occurs in babies born less than 31 weeks into pregnancy or weighing less than 3.3. pounds, affecting between 1,100 and 1,500 babies each year in the U.S., Regeneron said.