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Astellas Pharma Inc. has filed a supplemental New Drug Application (sNDA) with the FDA to include updated positive two-year data for Izervay (avacincaptad pegol intravitreal solution) in the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).1 The sNDA was based on findings from the randomized, double-masked, sham-controlled, multicenter Phase III GATHER2 trial (NCT04435366), which showed the drug lowered the rate of GA lesion growth across every month (EM) and every-other-month (EOM) dosing compared with sham through two years of therapy.2
“Astellas is committed to bringing innovative treatments to patients with retinal diseases including geographic atrophy,” said Carolyn Sasse, development head, Cell and Gene Therapy, Astellas Pharma, said in a press release. “We are pleased with the FDA’s decision to evaluate our application, and we look forward to working with the Agency throughout the review process.”1
Izervay, a complement C5 inhibitor, was approved by the FDA on August 4, 2023. It was the first GA treatment to demonstrate a statistically significant decrease (p<0.01) in GA progression at the 12-month primary endpoint, which was shown across both the Phase III GATHER1 (NCT02686658) and GATHER2 clinical trials.3
GATHER2 enrolled 448 patients with GA secondary to AMD to analyze the safety and efficacy of intravitreal administration of Izervay to compared with sham, which achieved the primary objective at 12 months. In the second year of the study, patients administered Izervay in the first year were re-randomized to receive either Izervay dosed EM (n=96) or EOM (n=93). Patients in the sham cohort the first year continued to receive it in year two (n=203).
Results from the trial show that Izervay continued to lower the rate of GA lesion growth in patients with GA secondary to AMD over two years compared with sham. This treatment benefit was observed as early as six months following initiation, and continued growing over time throughout two years, more than doubling over this timeframe compared to year one.
In terms of safety, Izervay was well tolerated over the two years of the GATHER2 trial. There was one case each of both non-serious intraocular inflammation and culture-positive endophthalmitis, and with no reported cases of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. Over the two years of the trial, incidence of choroidal neovascularization was 11.6% with Izervay compared with 9% in the placebo cohort.1
“GA is a chronic, progressive disease that can lead to irreversible vision loss,” said Veeral S. Sheth, MD, MBA, FACS, FASRS, partner and director of Clinical Trials University Retina, in a press release. “Having Izervay approved for longer-term use based on the latest safety and efficacy data would be a welcome development for the retina community.”1
Last month, the US Centers for Medicare and Medicaid Services assigned a Healthcare Common Procedure Coding System J-code for Izervay for the treatment of GA secondary to AMD, which went into effect April 1, 2024. The J-codes are used by payers and physicians to optimize the billing and reimbursement process for intravitreal injections and certain other therapies.4
“Receiving a permanent J-code in the US supports our efforts to increase timely patient access to Izervay, the first and only FDA approved GA treatment to demonstrate a statistically significant reduction in the rate of GA progression in just 12 months across two pivotal trials,” said Michael Petroutsas, head of US Commercial, in a press release.4
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of November 19, 2024, for the sNDA.
References
1. U.S. FDA Accepts Astellas’ Supplemental New Drug Application for IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy. Astellas Pharma Inc. News release. April 1, 2024. Accessed April 1, 2024. https://www.astellas.com/en/news/29016
2. IZERVAY™ (avacincaptad pegol intravitreal solution) Monthly or Every Other Month Reduced Geographic Atrophy Lesion Growth Through 2 Years. Astellas Pharma Inc. News release. November 6, 2023. Accessed April 1, 2024. https://www.astellas.com/en/news/28646
3. Iveric Bio Receives U.S. FDA Approval for IZERVAY™ (avacincaptad pegol intravitreal solution), a New Treatment for Geographic Atrophy. Astellas Pharma Inc. News release. August 5, 2023. Accessed April 1, 2024. https://www.astellas.com/en/news/28281
4. Astellas Receives Permanent J-code for IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy. Astellas Pharma Inc. News release. March 26, 2024. Accessed April 1, 2024. https://newsroom.astellas.us/2024-03-26-Astellas-Receives-Permanent-J-code-for-IZERVAY-TM-avacincaptad-pegol-intravitreal-solution-for-Geographic-Atrophy
