FDA Issues Complete Response Letter for Astellas' IZERVAY sNDA
核心洞察
The FDA issued a Complete Response Letter (CRL) to Astellas for its supplemental New Drug Application (sNDA) for IZERVAY on November 15, 2024.
The CRL was related to a statistical matter pertaining to proposed labeling language and not to the safety, efficacy, or risk of use for IZERVAY.
The sNDA sought to include positive two-year data from the GATHER2 Phase 3 clinical trial in the US Prescribing Information.
Astellas Pharma Inc. has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for avacincaptad pegol intravitreal solution (IZERVAY). The FDA communicated its decision on November 15, 2024, stating that it cannot approve the sNDA in its current form. The Prescription Drug User Fee Act (PDUFA) date for IZERVAY was expected to be November 19.
The CRL addresses a statistical issue related to the proposed labeling language for IZERVAY, and, according to Astellas, is not related to the safety, efficacy, or risk profile of the drug. The sNDA was submitted to include two-year data from the GATHER2 Phase 3 clinical trial in the US Prescribing Information. The GATHER2 trial evaluated the safety and efficacy of monthly and every-other-month dosing regimens of IZERVAY.
Astellas' Response
Astellas has stated its intention to seek further clarification from the FDA and collaborate with the agency to address the feedback. Marci English, Senior Vice President of Biopharma and Ophthalmology Development for Astellas Pharma, emphasized the company's confidence in IZERVAY's clinical profile, noting its statistically significant slowing of geographic atrophy (搜索) (GA) progression across two pivotal Phase 3 studies. "Astellas stands by the clinical profile of IZERVAY... While this is a disappointment for patients and physicians who rely on IZERVAY... Astellas is unwavering in our commitment to the ophthalmology space and will continue to work with the FDA to advance solutions for those suffering from GA."
Background on IZERVAY
IZERVAY was initially approved by the FDA on August 4, 2023, for the treatment of geographic atrophy (搜索) secondary to age-related macular degeneration (搜索) (AMD). The drug represents a significant advancement in the management of this progressive condition, which can lead to irreversible vision loss.