FDA approves amended label for Izervay for geographic atrophy
The approval follows a refiling after the FDA issued a Complete Response Letter due to language on the amended label.
(Image credit: Adobe Stock / ©Araki Illustrations)
The FDA approved a new, expanded version of the US Prescribing information for avacincaptad pegol intravitreal solution (Izervay; Astellas Pharma) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). With this approval, avacincaptad pegol is not limited on duration of dosing, encouraging flexibility for GA management for both patients and eye care providers.
In November 2024, the FDA issued a Complete Response Letter (CRL) for a supplemental New Drug Application (NDA) for avacincaptad pegol due to the language on the label. Astellas met with the FDA on December 20, 2024, and refiled an NDA on December 26, 2024, to reflect feedback from the FDA. The supplemental NDA sought to include positive 2-year data from the GATHER2 Phase 3 clinical trial, which evaluated the safety and efficacy of monthly and every-other-month dosing, in the US Prescribing information.
"We are pleased with the FDA's decision to extend the use of IZERVAY for longer-term administration—further solidifying IZERVAY's status as a trusted choice for thousands of GA patients since its launch in 2023,” Marci English, senior vice president of biopharma and ophthalmology development at Astellas Pharma, said in a press release. “To date, IZERVAY remains the only FDA-approved treatment to demonstrate a statistically significant slowing of GA across two pivotal studies."
The avacincaptad pegol intravitreal injection was approved by the FDA in August 2023 and received a permanent J-code in March 2024. As of the close of December 2024, over 210,000 vials of avacincaptad pegol were distributed, according to Astellas. The company also shares that post-marketing safety reporting remains consistent with clinical trial results, with no new or significant safety signals identified following the launch of Izervay.
"This is a welcome update for retina specialists, providing continued management options for treatment of this chronic, progressive disease that can lead to irreversible vision loss," Veeral S. Sheth, MD, MBA, FACS, FASRS, partner and director of clinical trials at University Retina, said in a press release.
