Astellas Pharma Inc. confirmed the FDA has accepted its revised supplemental new drug application (sNDA) for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
This news follows the federal agency issuing Astellas a company response letter (CRL) in November 2024, in which it rejected the company’s initial sNDA submission.
First thing’s first: an IZERVAY refresh.
A complement C5 inhibitor formulated to slow the progression of GA, IZERVAY was FDA-approved in August 2023 as the first and only GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint.
- See all the details (including clinical trial data) on its approval.
Its recommended dosage: 2 mg (0.1 mL of 20 mg/mL solution) is to be administered via intravitreal injection to each affected eye once a month (EM) for up to 12 months.
- On the news front: In March 2024, IZERVAY received a permanent J-code.
Now what’s this business about an sNDA?
As we previously reported, Astellas originally submitted this sNDA with the purpose of including 2-year clinical data within IZERVAY’s prescribing information (PI).
Some new information: After that submission—and the FDA’s subsequent rejection—the company stated that its sNDA was actually refiled after a meeting with the FDA on Dec. 20, 2024, in which the application was “designated as a Class 1 resubmission, with a 60-day review period.”
Go on …
A couple of notes about this:
- The product’s PI currently only includes data on IZERVAY up to a 12-month timeframe for both EM and every-other-month (EOM) dosings.
- This came from the phase 3 GATHER1 (NCT04435366) and GATHER2 (NCT04435366) trials.
- This 2-year data was reported from the phase 3 GATHER2 trial, which was conducted after the GATHER1 trial concluded.
And this boils down to …
Astellas is looking to add these positive 24-month findings as supporting data for IZERVAY’s approved on-label use—extending the drug’s permitted use to EM for an additional 12 months longer than its current approved dosing regimen.
As the company previously clarified to Glance: This 24-month dosing would include both EM and EOM dosing of IZERVAY.
Tell me more about that 24-month data.
First: This data built off initial positive topline data reported from the GATHER2 trial in September 2023—just one month after IZERVAY’s approval.
Next: The final clinical dataset was released in November 2023 and included participants who were re-randomized to be administered IZERVAY in both dosing forms (EM and EOM).
- The intent: Discerning whether, after re-randomization, IZERVAY continued to slow the GA growth rate among EM-dosed patients (vs sham-treated).
And did it?
Indeed it did. In fact, IZERVAY demonstrated a reduction in the rate of GA lesion growth as early as 6 months for both IZERVAY-treated patients (EM and EOM dosings) versus sham-treated patients.
Even better: That reduction actually continued to increase throughout the entire 24-month duration.
See the full findings—complete with number-specific stats and reported adverse events.
Nice! Last question: When might we hear about the FDA’s final verdict on this sNDA?
The target action date: Feb. 26, 2025.
As always, stay tuned!