• 03 Apr 2024
• Admin
• News Article

Astellas’ sNDA for Izervay Receives Approval

US FDA accepts Astellas’ sNDA for Izervay for the treatment of geographic atrophy

Overview

Astellas Pharma Inc. announced it received notification from the US Food and Drug Administration (FDA) of acceptance of the company’s supplemental New Drug Application (sNDA) to include positive 2-year data in the US Prescribing Information for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The sNDA is based on results from the GATHER2 phase 3 clinical trial, which evaluated the efficacy and safety of monthly (EM) and every other month (EOM) dosing through year 2.

Action Date Based on PDUFA

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of November 19, 2024. The acceptance follows the US Centers for Medicare and Medicaid Services issuing a permanent J-code for Izervay, effective April 1, 2024, which is expected to accelerate patient access in the US.

Words from Astellas Pharma

Carolyn Sasse, development head, cell and gene therapy, Astellas Pharma, said: “Astellas is committed to bringing innovative treatments to patients with retinal diseases including geographic atrophy. 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.”

GATHER2 Results

• The GATHER2 data demonstrated Izervay continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD through 2 years versus sham. 
• The treatment benefit with Izervay vs. sham was observed as early as 6 months, continued to increase over time through 2 years, and more than doubled over 2 years compared to year 1.
• Izervay was well tolerated over 2 years in GATHER2, with one case of non-serious intraocular inflammation (IOI) and culture-positive endophthalmitis each, and zero cases of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. 
• Over 2 years, the incidence of choroidal neovascularization (CNV) was slightly increased between Izervay (11.6%) versus sham (9%).

Words from Expert

Veeral S. Sheth, MD, MBA, FACS, FASRS, partner and director of Clinical Trials University Retina, said: “GA is a chronic, progressive disease that can lead to irreversible vision loss. Having Izervay approved for longer-term use based on the latest safety and efficacy data would be a welcome development for the retina community.”

Izervay was approved by the US Food and Drug Administration on August 4, 2023, for the treatment of GA secondary to AMD and is currently under review by the European Medicines Agency.

Astellas has already reflected the impact from this result in its financial forecast for the fiscal year ending March 31, 2024.

GATHER2 (NCT04435366) Trial

• GATHER2 (NCT04435366) was a randomized, double-masked, sham-controlled, multicenter phase 3 clinical trial to evaluate the safety and efficacy of intravitreal administration of avacincaptad pegol (ACP) in 448 enrolled patients with GA secondary to AMD. 
• ACP met its primary objective at 12 months, for which patients were randomized to receive either ACP or sham procedure monthly. 
• In year 2 of the study, patients treated with ACP in year 1 were re-randomized to receive either ACP dosed monthly (EM, n=96) or every other month (EOM, n=93); patients who received sham in year 1 continued to receive sham in year 2 (n=203). 
• Izervay is continuing to be evaluated in an open-label extension study.

US Indication: 

Izervay (avacincaptad pegol intravitreal solution) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

AMD

• Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. 
• The macula is a small area in the central portion of the retina responsible for central vision. 
• As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. 
• Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients.

About Astellas Pharma

• Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 
• The company is promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on biology and modality.