U.S. FDA Confirms Class 1 Resubmission of the Supplemental New Drug Application for IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy
Astellas Pharma announced that the FDA has accepted their revised supplemental New Drug Application (sNDA) for IZERVAY™ on January 6, 2025. The application, designated as a Class 1 resubmission with a 60-day review period, follows a Complete Response Letter from November 2024 and a subsequent meeting with the FDA on December 20, 2024.
IZERVAY™, which was initially approved by the FDA on August 4, 2023, is used for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The current sNDA aims to incorporate positive 2-year data from the GATHER2 Phase 3 clinical trial into the U.S. Prescribing Information. The FDA has set a target action date of February 26, 2025.
The company expects minimal impact on its financial results for the fiscal year ending March 31, 2025.
Astellas Pharma ha annunciato che la FDA ha accettato la loro domanda di revisione supplementare del Nuovo Farmaco (sNDA) per IZERVAY™ il 6 gennaio 2025. La domanda, designata come una risubmissione di Classe 1 con un periodo di revisione di 60 giorni, segue una Lettera di Risposta Completa del novembre 2024 e un incontro successivo con la FDA del 20 dicembre 2024.
IZERVAY™, approvato inizialmente dalla FDA il 4 agosto 2023, viene utilizzato per trattare l'atrofia geografica (GA) secondaria alla degenerazione maculare legata all'età (AMD). L'attuale sNDA mira a incorporare i dati positivi a 2 anni provenienti dallo studio clinico di Fase 3 GATHER2 nelle Informazioni di Prescrizione degli Stati Uniti. La FDA ha fissato una data obiettivo per l'azione del 26 febbraio 2025.
L'azienda si aspetta un impatto minimo sui suoi risultati finanziari per l'anno fiscale che si conclude il 31 marzo 2025.
Astellas Pharma anunció que la FDA ha aceptado su solicitud revisada de nuevo fármaco suplementario (sNDA) para IZERVAY™ el 6 de enero de 2025. La solicitud, designada como una resubmisión de Clase 1 con un período de revisión de 60 días, sigue a una Carta de Respuesta Completa de noviembre de 2024 y una reunión posterior con la FDA el 20 de diciembre de 2024.
IZERVAY™, que recibió inicialmente la aprobación de la FDA el 4 de agosto de 2023, se utiliza para tratar la atrofia geográfica (GA) secundaria a la degeneración macular relacionada con la edad (AMD). La actual sNDA tiene como objetivo incorporar datos positivos de 2 años del ensayo clínico GATHER2 de Fase 3 en la Información de Prescripción de EE. UU. La FDA ha establecido una fecha objetivo de acción para el 26 de febrero de 2025.
La empresa espera un impacto mínimo en sus resultados financieros para el año fiscal que finaliza el 31 de marzo de 2025.
아스텔라스 제약은 FDA가 IZERVAY™에 대한 수정된 보충 신약 신청(sNDA)을 2025년 1월 6일에 수락했다고 발표했습니다. 이번 신청은 60일 검토 기간을 가진 1급 재신청으로 분류되며, 2024년 11월의 완전 응답 서한과 2024년 12월 20일의 FDA와의 후속 회의에 이어 이루어졌습니다.
IZERVAY™는 2023년 8월 4일에 FDA의 승인을 처음으로 받은 약물로, 노화 관련 황반 퇴행(AMD)으로 인한 지리적 위축(GA) 치료에 사용됩니다. 현재의 sNDA는 GATHER2 3상 임상 시험에서 얻은 2년 긍정적인 데이터를 미국 처방 정보에 포함시키는 것을 목표로 하고 있습니다. FDA는 2025년 2월 26일을 목표 행동 날짜로 설정했습니다.
회사는 2025년 3월 31일로 종료되는 회계연도의 재무 결과에 미치는 영향이 최소화될 것이라고 예상하고 있습니다.
Astellas Pharma a annoncé que la FDA a accepté sa demande de nouveau médicament complémentaire (sNDA) révisée pour IZERVAY™ le 6 janvier 2025. La demande, désignée comme une resurmission de Classe 1 avec une période de révision de 60 jours, fait suite à une Lettre de Réponse Complète de novembre 2024 et à une réunion subséquente avec la FDA le 20 décembre 2024.
IZERVAY™, qui a été initialement approuvé par la FDA le 4 août 2023, est utilisé pour traiter l'atrophie géographique (GA) secondaire à la dégénérescence maculaire liée à l'âge (AMD). L'actuelle sNDA vise à intégrer des données positives de 2 ans de l'étude clinique de phase 3 GATHER2 dans les Informations de Prescription des États-Unis. La FDA a fixé une date d'action cible au 26 février 2025.
L'entreprise s'attend à un impact minimal sur ses résultats financiers pour l'exercice se terminant le 31 mars 2025.
Astellas Pharma gab bekannt, dass die FDA ihren überarbeiteten Antrag auf ergänzende neue Arzneimittelzulassung (sNDA) für IZERVAY™ am 6. Januar 2025 angenommen hat. Der Antrag, der als Wiederantrag der Klasse 1 mit einer Überprüfungsfrist von 60 Tagen eingestuft wird, folgt auf einen vollständigen Antwortbrief vom November 2024 und einem nachfolgenden Treffen mit der FDA am 20. Dezember 2024.
IZERVAY™, das ursprünglich am 4. August 2023 von der FDA genehmigt wurde, wird zur Behandlung der geografischen Atrophie (GA) eingesetzt, die sekundär zur altersbedingten Makuladegeneration (AMD) auftritt. Die aktuelle sNDA zielt darauf ab, positive 2-Jahres-Daten aus der GATHER2 Phase-3-Studie in die US-Verschreibungsinformation aufzunehmen. Die FDA hat den Zieltermin für Maßnahmen auf den 26. Februar 2025 festgelegt.
Das Unternehmen erwartet minimale Auswirkungen auf seine finanziellen Ergebnisse für das zum 31. März 2025 endende Geschäftsjahr.
- FDA accepted the revised sNDA for IZERVAY with a fast 60-day review period
- Class 1 resubmission designation indicates minor changes to the application
- Potential inclusion of positive 2-year clinical trial data in prescribing information
- None.
A target action date has been set for February 26, 2025.
IZERVAY was approved by the
The sNDA seeks to add positive 2-year data to the IZERVAY
The impact of this matter on Astellas' financial results for the fiscal year ending March 31, 2025, is expected to be minor.
About IZERVAY™ (avacincaptad pegol intravitreal solution)
What is IZERVAY?
IZERVAY (avacincaptad pegol intravitreal solution) is a prescription eye injection, used to treat geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD).
What is the most important information I should know about IZERVAY?
Do NOT receive IZERVAY if you:
- Have an infection in or around your eye
- Have active swelling in or around your eye that may include pain and redness
IZERVAY can cause serious side effects:
- Eye injections like the one for IZERVAY can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment).
- Call your healthcare provider right away if you have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in your vision, flashes of light, or increased sensitivity to light.
- There is a risk of developing wet AMD with IZERVAY. You should report any symptoms (visual distortions such as straight lines seeming bent, deterioration in vision, dark spots, loss of central vision) to your healthcare provider to monitor.
- IZERVAY may cause a temporary increase in eye pressure after the injection. Your healthcare provider will monitor this after each injection.
Before receiving IZERVAY tell your healthcare provider about all of your medical conditions including if you:
- Have a history of seeing flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks.
- Have high pressure in the eye or if you have glaucoma.
- Are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
- Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider about any medicine you take.
What should I avoid while receiving IZERVAY?
- Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently.
What are the most common side effects of IZERVAY?
- Blood in the white of the eye
- Increase in eye pressure
- Blurred vision
- Wet age-related macular degeneration
These are not all the possible side effects of IZERVAY. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information for more information.
About Geographic Atrophy
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 the GATHER2 Clinical 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.
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
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SOURCE Astellas Pharma Inc.
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