Astellas Pharma Inc. (TSE: 4503) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on November 15, 2024, regarding the supplemental New Drug Application (sNDA) for IZERVAY™ (avacincaptad pegol intravitreal solution). The sNDA aimed to incorporate positive two-year data from the GATHER2 Phase 3 clinical trial into the U.S. Prescribing Information for IZERVAY. This trial evaluated the drug’s efficacy and safety for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The FDA indicated that the current application could not be approved by the November 19, 2024, Prescription Drug User Fee Act (PDUFA) action date. The CRL identified a statistical issue related to the proposed labeling language but noted that this does not pertain to IZERVAY’s safety or its benefit-risk profile.
Astellas is engaging with the FDA to clarify and address the concerns raised and aims to resolve the matter promptly.
Astellas Leadership Commentary
Marci English, Senior Vice President, Biopharma and Ophthalmology Development at Astellas, reaffirmed the company’s confidence in IZERVAY’s clinical profile. “IZERVAY is the only FDA-approved treatment for GA that consistently demonstrated statistically significant slowing of disease progression across two pivotal Phase 3 studies. While this development is disappointing for patients and physicians managing this chronic, progressive condition, we remain committed to advancing solutions for those affected by GA.”
Background on IZERVAY
IZERVAY was approved by the FDA on August 4, 2023, for the treatment of GA secondary to AMD. The therapy remains a key option for slowing the progression of a condition that can lead to irreversible vision loss.
Important Safety Information
- Indication: IZERVAY is indicated for the treatment of GA secondary to AMD.
- Contraindications: Patients with ocular or periocular infections or active intraocular inflammation should not use IZERVAY.
- Warnings and Precautions:
- Endophthalmitis and Retinal Detachments: Ensure proper aseptic techniques during administration. Patients should promptly report symptoms suggestive of these conditions.
- Neovascular AMD: Increased rates of wet AMD have been observed in clinical trials. Patients should be monitored for signs of neovascularization.
- Intraocular Pressure Increases: Monitor and manage transient IOP spikes that may occur post-injection.
- Common Adverse Reactions: Reported side effects include conjunctival hemorrhage, increased IOP, blurred vision, and neovascular AMD.
Astellas is assessing potential financial impacts of the FDA’s decision for the fiscal year ending March 31, 2025. Meanwhile, the company remains dedicated to supporting the ophthalmology community and patients relying on innovative therapies like IZERVAY.
