FDA Issues Complete Response Letter for Astellas' Izervay sNDA
核心洞察
The FDA issued a Complete Response Letter (CRL) for Astellas' supplemental New Drug Application (sNDA) for Izervay on November 15.
The CRL does not raise concerns regarding the safety, efficacy, or risk profile of Izervay, according to Astellas.
The FDA's decision is related to a statistical matter pertaining to the proposed labeling language for the product.
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 issued the CRL on November 15, stating that it cannot approve the sNDA in its current form. The Prescription Drug User Fee Act (PDUFA) date for the sNDA was expected to be November 19.
According to Astellas, the FDA's comments in the CRL are not related to the safety, efficacy, or risk of use associated with Izervay. Instead, the CRL pertains to a statistical matter concerning the proposed labeling language for the product. The sNDA sought to include positive 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.
The company intends to seek further clarification from the FDA and collaborate with the agency to address the feedback promptly. Marci English, Senior Vice President of Biopharma and Ophthalmology Development for Astellas Pharma, stated that Astellas stands by the clinical profile of Izervay, highlighting its consistent demonstration of statistically significant slowing of geographic atrophy (搜索) (GA) across two pivotal Phase 3 studies. She acknowledged the disappointment for patients and physicians who rely on Izervay for managing GA, a chronic, progressive disease that can lead to irreversible vision loss. English affirmed Astellas' commitment to the ophthalmology space and its dedication to working with the FDA to advance solutions for those affected by GA.
Background on Izervay
Izervay was initially approved by the US FDA on August 4, 2023, for the treatment of geographic atrophy (搜索) (GA) secondary to age-related macular degeneration (搜索) (AMD). The sNDA aimed to expand the prescribing information with additional data from the GATHER2 trial, reinforcing the drug's efficacy over a longer period.