In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med Izervay has nabbed a much-needed label update from the FDA.
The agency lifted its previous 12-month limitation on the drug’s approved label, allowing physicians and patients “greater flexibility” when managing GA secondary to age-related macular degeneration, according to Astellas' Feb. 12 press release. Previously, Izervay’s label stipulated that the treatment was recommended “for up to 12 months.”
The company is “pleased” with the FDA’s decision on longer-term use of the medicine. The label update reinforces "Izervay’s status as a trusted choice for thousands of GA patients since its launch in 2023,” Astellas' senior vice president of biopharma and ophthalmology development, Marci English, said in the release.
It’s a turnaround from the FDA’s original rejection of the label update, which came in the form of a November complete response letter. The regulatory setback resulted in a temporary slowdown in the launch, Astellas executives said on a recent earnings call.
Under the prior label, Astellas had heard that many retina specialists were pausing Izervay use for patients who reached the 12-month mark. On Astellas' recent call, chief financial officer Atsushi Kitamura said he expected patients would “quickly resume” treatment after the label update.
Izervay shares the GA market with Apellis' Syfovre, which until now held the treatment-duration edge over Astellas' offering.
Astellas' label update did not add on every-other-month dosing, which the company had originally requested. However, clinical data for that aspect of the drug's studies is mentioned in the efficacy section of the new label, William Blair analyst Lachlan Hanbury-Brown pointed out in a note to clients.
Syfovre, meanwhile, can be used monthly or every other month, or specifically once every 25 to 60 days. Apellis touts the drug as the only to slow GA in "as few as 6 doses per year."
The FDA’s about-face on Astellas' drug stands to represent the “reversal of a small bump” that Syfovre has experienced in the wake of the complete response letter, Lachlan Hanbury-Brown wrote in his note.
In the long run, though, the analyst maintains that Apellis’ offering has blockbuster potential in GA. Its “superior efficacy relative to competitor Izervay will ultimately drive significant market share as physicians move beyond a focus on safety," the analyst wrote.
The analyst pointed to the data in the drugs' FDA labels, highlighting that monthly Izervay yields a 14% reduction in observed lesion growth after 24 months compared to an 18.1% and 21.9% decrease in the rate of GA lesion growth for monthly Syfovre and similar results for every-other-month Syfovre.
Astellas executives have pushed back against similar assertions made through cross-trial comparisons, arguing that claims of Syfovre’s relative efficacy over Izervay can’t be made without a head-to-head study.