I nuovi farmaci modulatori per la proteina CFTR: a che punto siamo?

07/04/2017

Disponiamo al momento di un solo farmaco, immesso sul mercato: il Kalydeco® (ivacaftor), un potenziatore della proteina CFTR, autorizzato dall’AIFA (05/05/2015) per i pazienti con fibrosi cistica di età superiore ai 6 anni, che hanno almeno una delle seguenti
mutazioni di “gating” (classe III): G551D, D1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R. Il farmaco è prescrivibile e distribuito dalle farmacie territoriali, con compilazione di un registro nazionale, monitorato dall’AIFA.
Il Kalydeco® non è stato ancora approvato da AIFA per due indicazioni aggiuntive: a) bambini di età compresa tra i 2 ed i 5 anni (approvazione FDA il 18/03/2015, dell’EMEA il 18/11/2015), che hanno almeno una delle 9 mutazioni sopra indicate; b) soggetti di età
superiore ai 18 anni ed almeno una mutazione R117H.
Orkambi® (correttore di 1° generazione lumacaftor + potenziatore ivacaftor) ha ricevuto l’approvazione della FDA il 12/5/2015 e dell’EMEA il 20/11/2015 per essere somministrato in soggetti di età superiore ai 12 anni con la doppia mutazione F508del. Questo
farmaco è stato fornito nel gennaio-febbraio 2016 con la modalità del cosiddetto “uso compassionevole”, a carico di Vertex che lo produce e lo ha sperimentato, a 3/4 pazienti che hanno partecipato ai progetti di ricerca di fase 3 con questo farmaco, e a 14 pazienti che presentavano compromissione avanzata della situazione polmonare o instabilità clinica e declino della funzione polmonare. La modalità “compassionevole”, sostenuta per le spese dalle aziende farmaceutiche, richiede l’autorizzazione del Comitato Etico aziendale, che lo prevede per un farmaco ancora in studio, non registrato ed autorizzato dalle agenzie preposte: è riservata a quei pazienti che non avrebbero potuto essere inclusi negli studi clinici per gravità
della situazione polmonare. Questo programma è stato chiuso circa un anno fa; abbiamo fatto la richiesta alla Regione di acquistare il farmaco per ulteriori 3 pazienti con condizioni cliniche instabili ed in aggravamento e la nostra richiesta è stata accolta.
I risultati pubblicati dei trial clinici ma anche la nostra osservazione nei 17 pazienti ci indicano che: i) un quarto dei pazienti ha registrato un effetto benefico evidente di Orkambi® sulla funzione polmonare (spirometria: FEV1), stato nutrizionale, numero delle esacerbazioni
polmonari, sintomi respiratori; ii) l’incremento medio del FEV1 ottenuto con la combinazione dei due farmaci è di 3 punti di percento predetto, che è inferiore a quello ottenuto da Kalydeco® nei soggetti con fibrosi cistica ed una mutazione di “gating” (incremento medio del FEV1 di 10 punti di percento predetto); iii) non è possibile predire quali soggetti sono “responders”; iv) il farmaco è stato ben tollerato (temporanei sono stati i disturbi respiratori registrati in chi aveva una compromissione respiratoria avanzata); v) il costo del farmaco è elevato (circa 250.000 Euro/anno/paziente).
E’ ancora in corso la valutazione e la contrattazione sul prezzo da parte di AIFA. Sembra che l’orientamento dell’agenzia italiana sia favorevole all’immissione in commercio, pur con le seguenti condizioni: i) registrazione di effetti positivi e negativi in un registro centralizzato AIFA; ii) sostenere la spesa per l’acquisto del farmaco solo se questo si valuta efficace, tenendo conto dei parametri scelti e monitorati nel registro, e perciò sua eventuale sospensione nel caso d’inefficacia. Seguiremo le indicazioni di AIFA per la prescrizione di
questo farmaco.
Cosa si sta muovendo sul fronte della ricerca clinica e delle richieste di autorizzazione alle agenzie dei farmaci?
• PTC ha interrotto la sperimentazione con Ataluren (PTC124) nei soggetti di età superiore ai 12 anni con almeno una mutazione di “non senso” (classe I), per mancanza di efficacia del farmaco. Sono in fase di studio preclinico nuove strategie e altri farmaci simili per effetto ad Ataluren (es. G418), da associare ad ivacaftor.
• Vertex avvierà nell’autunno 2017 trial clinici di fase 3 con correttori di seconda generazione, associando il correttore VX-440 (2° generazione) al correttore VX-661 (1° generazione) e al potenziatore ivacaftor nei soggetti con una o due mutazioni F508del.
• Sono in corso studi clinici di fase 2 per il potenziatore CTP-656 (Concert Pharma), i correttori BAY 63-2521 (Bayer), FDL169 (Flatley) e GLPG 1837 (Galapagos-Abbvie).
• AIFA dovrà pronunciarsi per l’uso di Orkambi® nei bambini tra 6 e 11 anni.
• Vertex sostiene i costi per la somministrazione in uso “compassionevole” di: Kalydeco®
nei pazienti con almeno una mutazione che ha dimostrato di avere una “funzione residua” della proteina CFTR (sufficienza pancreatica) e Orkambi® nei soggetti con doppia mutazione F508del di età tra i 6 e gli 11 anni.
• Vertex ha iniziato il percorso di richiesta di autorizzazione (FDA –> EMEA –> AIFA) per
la combinazione del correttore di prima generazione tezacaftor (VX-661) con il potenziatore ivacaftor per i soggetti di età superiore ai 12 anni con la doppia mutazione F508del o i soggetti con una mutazione F508del + una mutazione a “funzione residua” (sufficienza pancreatica).
Nel campo della correzione del difetto mutazione-specifico della proteina CFTR sono stati raggiunti iniziali risultati incoraggianti. Si sta aprendo un panorama meglio definito nel tentativo di incidere su tutte le mutazioni in gioco: diverse sono le aziende farmaceutiche che
competono in questo campo, diverse sono le strategie che si stanno ipotizzando o mettendo a punto, molti sono i pazienti che con entusiasmo partecipano alla ricerca clinica. Si è aperta una fase nuova della cura della malattia ed il nostro Centro vuole esserne protagonista!

A cura di Dr Cesare Braggion

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