Navigating regulatory hurdles in the U.S. and Europe, plus fierce competition from rival Apellis, Astellas’ geographic atrophy (GA) med Izervay has taken a few beatings in recent months. Still, the Japanese drugmaker is chasing the light it sees in an upcoming FDA decision.
Izervay pulled down $107 million in sales in the last three months of 2024, up merely 4% on a quarter-over-quarter basis. It marked a significant slowdown for the drug considering it remains in its early launch phase, delivering 26% sequential growth in the prior quarter.
The rollout suffered a “temporary impact” from the FDA's "unexpected" decision to reject a label update for Izervay in GA secondary to age-related macular degeneration (AMD) as well as changes in inventory levels, Astellas Chief Financial Officer Atsushi Kitamura said on a conference call Tuesday.
With its label-expansion bid, the company hopes to include in the drug's label positive two-year trial results for monthly and every-other-month dosing of Izervay in patients who have GA secondary to AMD. The drug's current label states that it's recommended "for up to 12 months."
While the FDA rejection was not about any benefit-risk concerns, Astellas has heard that many retina specialists are pausing Izervay use for patients who have reached 12 months on the drug. For Astellas' launch, the good news is that the company has "rarely heard of switching to a competitive drug,” Kitamura said, emphasizing that patients will likely “quickly resume” treatment upon the expected label update.
Following that setback, the company is now back on track with a new FDA decision date slated for Feb. 26, it announced in its quarterly earnings report.
Given the quick turnaround on the resubmission, the FDA’s requested changes may have been “relatively minor,” William Blair analyst Lachlan Hanbury-Brown pointed out in a note to clients. Astellas had described the FDA’s comments at the time as focused on a “statistical matter” related to proposed labeling language. Still, the “negative optics” of the original rejection could hurt Izervay from a competitive standpoint, the analyst said
Syfovre competition
As to why patients aren’t switching to Apellis’ rival Syfovre in the meantime, Astellas' chief commercial officer Claus Zieler highlighted the established safety profile of Izervay.
Syfovre and Izervay have been rubbing elbows in the GA market since Izervay launched six months after Syfovre in 2023. In its recent financial report, Astellas called Izervay the leading treatment option for new patient starts, boasting 60% of the new patient market share from October to November and 40% of the total market share.
Between the two, Hanbury-Brown maintained in William Blair’s recent note that Apellis’ rival Syfovre stands to grab “significant” market share and has blockbuster potential due to its superior efficacy over Izervay.
Astellas executives pushed back against similar assertions raised during the conference call that Syfovre has the efficacy edge over Izervay. Zieler argued that those statements are based on cross-trial comparisons and cannot be made without a head-to-head study.
“What you can say, however, is that our safety profile is in line with our clinical study, and I don’t think Apellis can say that about its competitor drug,” Zieler remarked.
Shortly after its launch, Syfovre was linked to rare but serious reports of a type of eye inflammation called retinal vasculitis. After an investigation, the company homed in on “variations” on the filter needle included in some injection kits as the possible culprit, but it couldn’t conclusively determine that the needles were to blame.
European hurdles
In Europe, neither drug has made it onto the market. Astellas clawed back its marketing authorization application in October following discussions with the European Medicines Agency, while Syfovre has been rejected twice by the regulator.
The European pullback prompted a 115.1 billion Japanese yen ($760 million) impairment charge at Astellas during the quarter.
That doesn’t mean Astellas is throwing in the towel on its global prospects. Reaching more patients worldwide is “extremely important,” Kitamura stressed. Along with a newly submitted application in its home country of Japan, the company has begun individual discussions with regulatory authorities in major countries and will “consider” a submission in Europe after it concludes discussions with officials there.
Along with its Izervay impairment, Astellas also booked a 51.8 billion Japanese yen ($339 million) impairment loss on its myotonic dystrophy gene therapy prospect AT466 as the “development timeline and the competitive environment have changed from our initial assumptions,” Kitamura explained. Including another charge on terminated medical devices projects, the quarter’s impairments altogether totaled 180 billion Japanese yen ($1.18 billion).
Over the last nine months of 2024, the company’s total revenue reached 1.45 trillion Japanese yen ($9.52 billion), a 22% jump from the same period last year. The bulk of sales came from Pfizer-partnered prostate cancer med Xtandi and bladder cancer antibody-drug conjugate Padcev, the latter of which saw a 110.4% sales jump to 117 billion Japanese yen ($767 million).