Astellas Pharma Inc. (TSE: 4503) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental New Drug Application (sNDA) for IZERVAY™ (avacincaptad pegol intravitreal solution) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The sNDA aimed to include two-year data from the GATHER2 Phase 3 trial in IZERVAY’s U.S. Prescribing Information, highlighting efficacy and safety with monthly and every-other-month dosing.
FDA Feedback
The FDA stated it could not approve the sNDA in its current form by the Prescription Drug User Fee Act (PDUFA) date of November 19, 2024. The CRL does not raise concerns about IZERVAY’s safety or benefit-risk profile but points to a statistical issue related to the labeling language proposed by Astellas.
Astellas Response
Astellas is engaging with the FDA to clarify the feedback and address the agency’s concerns swiftly.
Marci English, Senior Vice President, Biopharma and Ophthalmology Development at Astellas, commented:
“Astellas stands by IZERVAY’s clinical profile, the only FDA-approved GA treatment to show consistent, statistically significant slowing of GA progression in two pivotal Phase 3 trials. While this outcome is disappointing for patients and physicians managing this chronic and progressive disease, Astellas remains committed to advancing solutions for GA and working closely with the FDA.”
Astellas continues to support the ophthalmology community and the patients relying on innovative treatments like IZERVAY.
