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Astellas Pharma announces US FDA confirms Class 1 resubmission of the sNDA for Izervay for geographic atrophy

Tokyo
Saturday, January 11, 2025, 10:00 Hrs  [IST]

Astellas Pharma Inc. announced the US Food and Drug Administration (FDA) accepted the revised supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on January 6, 2025, in response to the Agency’s November 2024 Complete Response Letter (CRL). The application was refiled following a December 20, 2024, meeting between the FDA and Astellas and has been designated as a Class 1 resubmission, with a 60-day review period.

A target action date has been set for February 26, 2025.

Izervay was approved by the US Food and Drug Administration on August 4, 2023, for the treatment of GA secondary to AMD.

The sNDA seeks to add positive 2-year data to the Izervay US Prescribing Information based on results from the GATHER2 phase 3 clinical trial.

The impact of this matter on Astellas’ financial results for the fiscal year ending March 31, 2025, is expected to be minor.

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.

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.

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. The company provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health.

 

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