Pegcetacoplan approvato dalla FDA per l’atrofia geografica secondaria alla AMD
18 febbraio 2023
Apellis ha ricevuto l’approvazione della FDA per l’utilizzo di pegcetacoplan intravitreale (SYFOVRE) nel trattamento dell’atrofia geografica secondaria alla AMD. Questa notizia segue la presentazione dei dati di fase 3 di 24 mesi nel novembre 2022.
La FDA ha approvato l’utilizzo di pegcetacoplan intravitreale (SYFOVRE; Apellis) per il trattamento dell’atrofia geografica (GA) secondaria alla degenerazione maculare legata all’età (AMD) sulla base dei risultati dei dati di fase 3 di 24 mesi presentati nella sua Nuova Domanda di Farmaco nel novembre 2022.
“L’approvazione di SYFOVRE è l’evento più importante dell’oftalmologia retinica degli ultimi dieci anni”, ha dichiarato Eleonora Lad, MD, PhD, investigatore principale dello studio OAKS, direttore della ricerca clinica oftalmologica e professore associato di oftalmologia presso il Duke University Medical Center, in una dichiarazione preparata. “Fino ad ora non esistevano terapie approvate per offrire alle persone che vivono con GA una soluzione mentre la loro vista declinava implacabilmente. Con SYFOVRE, abbiamo finalmente una terapia GA sicura ed efficace per questa malattia devastante, con effetti crescenti nel tempo”.
L’inclusione dei dati di 24 mesi, ha spiegato l’azienda, ha rafforzato il profilo del prodotto al momento del lancio, con un impatto minimo sui tempi di lancio, ed è stata considerata una modifica significativa alla Nuova Domanda di Farmaco, estendendo il periodo di revisione di 3 mesi.
I dati di efficacia di 24 mesi sono stati ottenuti dagli studi di fase 3 DERBY e OAKS. Secondo un comunicato stampa, “Questi dati hanno mostrato effetti importanti con il trattamento mensile e con ogni successivo mese di pegcetacoplan in entrambi gli studi.
I dati di sicurezza di 24 mesi sono stati presentati in precedenza come parte dell’aggiornamento di 120 giorni”.
L’azienda Apellis ha sottolineato che i dati di fase 3 di 24 mesi “hanno dimostrato effetti importanti e crescenti nel tempo”. I dati a lungo termine hanno fornito un profilo del prodotto ancora più sicuro al momento del lancio”, secondo Cedric Francois, MD, PhD, amministratore delegato e co-fondatore di Apellis.
Gli studi OAKS (n = 621) e DERBY (n = 637) sono studi di fase 3, multicentrici, randomizzati, a doppio cieco, controllati con placebo, che confrontano l’efficacia e la sicurezza di pegcetacoplan con iniezioni di placebo in una vasta e rappresentativa popolazione di pazienti con atrofia geografica (GA) secondaria alla degenerazione maculare legata all’età (AMD).
L’obiettivo principale degli studi era di valutare l’efficacia di pegcetacoplan mensile e ogni altro mese nei pazienti con GA valutati mediante variazione dell’area totale delle lesioni GA rispetto al basale misurata mediante autofluorescenza del fondo oculare a 12 mesi.
I pazienti hanno continuato a ricevere il trattamento mascherato per 24 mesi.
Le conclusioni di questi studi sono importantissimi in quanto danno una tangibile speranza ai pazienti affetti da maculopatia degenerativa atrofica geografica della retina.
Buona sera
vorrei sapere se il PEGCETACOPLAN è autorizzato in Italia e se il vostro centro somministra queste cure.
Salve,
La EMA, l’Agenzia Europea dei Medicinali, sta esaminando una domanda di autorizzazione all’immissione in commercio per SYFOVRE, un farmaco per il trattamento dell’atrofia geografica. La decisione sull’autorizzazione è prevista per l’inizio del 2024.
Quindi, la risposta alla tua domanda è: non ancora. SYFOVRE non è ancora disponibile in Italia, ma lo sarà probabilmente entro i primi mesi del 2024.
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