Super dwog Xofluza Roche a te apwouve pa Ewop la: Yon sel doz oral ka byen vit touye Viris la!

Roch denyeman te anonse ke Komisyon Ewopeyen an (EC) te apwouve Xofluza: (1) pou pasyan ≥12 ane fin vye granmoun nan trete enfliyanza san konplike; (2) pou moun ≥12 ane fin vye granmoun pou tretman prevantif apre enfliyanza ekspoze. Objektif la nan pos-ekspoze tretman pwofetik se yo anpeche moun ki soti nan kontrarye enfliyanza apre kontak ak yon moun ki enfliyanse viris-enfekte. Apwobasyon sa a baze sou done ki soti nan 3 faz III etid klinik (CAPSTONE-1, CAPSTONE-2, ak BLOCKSTONE).

Li se vo mansyone ke Xofluza se premye dwog la anti-enfliyanza ak yon mekanis inovate nan aksyon ki apwouve pa Inyon Ewopeyen an nan ane ki sot pase 20. Ozetazini, Xofluza se tou premye dwog la anti-enfliyanza ak yon mekanism nouvo apwouve pa FDA a nan 20 ane ki sot pase yo. Nan ese klinik, yon tretman sel ak Xofluza ka siyifikativman redwi dire a nan sentom grip ak siyifikativman diminye ekskresyon viris nan jis yon sel jou.

Enfliyanza se youn nan maladi ki pi komen men ki grav enfektye, poze yon menas pi gwo nan sante piblik. Globalman, enfliyanza lakoz 3 a 5 milyon maladi grav chak ane, de milyon de moun yo entene lopital, ak jiska 650,000 moun mouri. Xofluza ka byen vit diminye replikasyon viris, ede pasyan refe pi vit, epi redwi chay sosyal la nan enfliyanza.

Ofisye Medikal Rochef ak Tet devlopman pwodwi Global Levi Garraway, MD, te di: "Nou kontan anpil ke Komisyon Ewopeyen an apwouve Xofluza, ki se premye dwog la sel-doz oral pou tretman an nan enfliyanza. Xofluza pral bay pasyan an Ewop ak dwog nan premye sel-doz nan preske 20 ane yon mekanis nouvo nan mekanis anti-enfliyanza. Avek apwobasyon nan tretman ak pos-ekspoze prevansyon, nou espere ke Xofluza ka ede pasyan refe pi vit, pandan yo ap diminye chay sosyal la nan grip, espesyalman nan konteks la nan pandemik la COVID-19."

Xofluza se yon mekanis premye-an-an-, dwog sel-doz oral ak yon mekanis anti-enfliyanza nouvo nan aksyon. Dwog la se yon inibite andonuklease ki fet yo anpeche estrikti nan kap CAP nan enfliyanza viris Depandan endonuklease, ki se esansyel pou enfliyanza replikasyon viris. Xofluza fet yo konbat enfliyanza A ak B viris, ki gen ladan Tamiflu (oseltamivir, oseltamivir) reziste kont souch enfliyanza ak souch avyon enfliyanza (H7N9, H5N1).

Xofluza te dekouvri pa Yoshino Shiono, ak ansanm devlope pa Roche ak Yoshino Shiono atrave lemond. Dapre ako a, Roche jwi dwa mondyal pou dwog la nan lot zon ke Japon ak Taywann. Se konsa, lwen, Xofluza te apwouve pou tretman an nan grip A ak B nan plis pase 30 peyi yo. Ozetazini, endikasyon Xofluza apwouve gen ladan: (1) Pou moun ki an sante ≥12 ane fin vye granmoun oswa moun ki gen gwo risk pou konplikasyon enfliyanza ki gen rapo ak grav, trete ak enfliyanse san konplike ak sentom ki pa depase 48 edtan; (2) Pou moun ≥12 ane fin vye granmoun, pou tretman prevantif apre ekspoze enfliyanza.

Xofluza se premye a epi selman sel-doz dwog apwouve pou tretman an nan enfliyanza ak premye dwog la nouvo enfliyanza ak yon mekanis nouvo nan aksyon nan ane ki sot pase yo 20. Gen prev klinik fo ki Xofluza gen benefis ki ka gerizon pou popilasyon miltip (popilasyon enfliyan sante, popilasyon nan risk ki wo nan konplikasyon enfliyanza, timoun) ak anviwonman tretman (enfliyans senptom, post-ekspozisyon). Kounye a, Xofluza yo te evalye nan yon faz III pwoje devlopman klinik, ki gen ladan timoun ki poko gen yon ane fin vye granmoun (NCT03653364), pasyan lopitalize ak gwo enfliyanza grav (NCT03684044), ak evalye posibilite pou diminye gaye nan enfliyanza soti nan moun ki enfekte nan moun ki an sante (NCT0396912).

Apwobasyon sa a baze sou rezilta faz 3 CAPSTONE-1, CAPSTONE-2, ak syans BLOCKSTONE.

--CAPSTONE-1 etid: Yon total de 1436 pasyan ki an sante (laj ≥12 ane fin vye granmoun) dyagnostike ak enfliyanza te enskri. Yon doz sel nan Xofluza te konbine avek yon plasbo ak anti-enfliyanza dwog oseltamivir (non komes: Tamiflu, chak jou 75mg de fwa pou jou 5) yo te konpare. Rezilta yo te montre ke konpare ak plasbo, Xofluza siyifikativman pi kout dire a nan sentom grip (medyan tan: 53.7 edtan vs 80.2 edtan, p<0.0001), and="" significantly="" shortened="" the="" duration="" of="" fever="" (median="" time:="" 24.5="" hours="" vs="" 42.0="" hours,="" p="" ＜0.0001).="" in="" addition,="" compared="" with="" placebo="" and="" oseltamivir,="" xofluza="" also="" significantly="" shortened="" the="" duration="" of="" virus="" release="" from="" the="" body="" (median="" time:="" 24.0="" hours="" for="" xofluza,="" 96.0="" hours="" for="" placebo,="" 72.0="" hours="" for="" oseltamivir,="" p="" ＜0.0001).="" in="" this="" study,="" xofluza="" was="" well="" tolerated,="" and="" the="" overall="" incidence="" of="" adverse="" events="" was="" slightly="" lower="" than="" that="" of="" the="" placebo="" and="" oseltamivir="">

--CAPSTONE-2 etid: Yon total de 2184 matye (laj ≥12 ane fin vye granmoun) nan konplikasyon gwo nan konplikasyon enfliyanza te enskri. Yon doz sel nan Xofluza (40mg oswa 80mg, dapre pwa ko) te konbine avek pwa oswa oseltamivir (2 chak jou). 75mg chak fwa pou jou 5) pou konparezon. Rezilta yo te montre ke konpare ak plasbo, Xofluza siyifikativman pi kout tan nan remisyon nan sentom grip (medyan tan: 73.2 edtan vs 102.3 edtan, p<0.0001). in="" patients="" with="" influenza="" b,="" xofluza="" showed="" better="" efficacy="" than="" placebo="" and="" tamiflu="" (shortening="" the="" time="" to="" remission="" of="" flu="" symptoms:="" median="" time="" was="" 74.6="" hours,="" 100.6="" hours,="" and="" 101.6="" hours,="" respectively,="" p="0.0138," p="0.0251" ).="" in="" addition,="" compared="" with="" placebo,="" xofluza="" significantly="" shortens="" the="" time="" to="" fever,="" reduces="" the="" incidence="" of="" flu-related="" complications,="" reduces="" the="" use="" of="" systemic="" antibiotics,="" and="" the="" time="" to="" stop="" virus="" excretion.="" compared="" with="" oseltamivir,="" xofluza="" significantly="" shortens="" the="" sustained="" release="" time="" of="" the="" virus="" from="" the="" body="" (median="" time:="" 48="" hours="" vs="" 96="" hours,=""><0.0001). in="" this="" study,="" xofluza="" was="" well="" tolerated,="" and="" the="" overall="" incidence="" of="" adverse="" events="" was="" slightly="" lower="" than="" that="" of="" the="" placebo="" and="" oseltamivir="">

--BLOCKSTONE etid: yon owaza, plasbo-kontwole, etid prevansyon pos-ekspoze, enskri nan gwoup la se matye ki an sante (granmoun ak timoun) ki gen manm fanmi yo konfime yo dwe enfliyanza-enfekte pa tes rapid enfliyanza dyagnostik (sa vle di, "enstriksyon ka [endeks pasyan]"). Matye sa yo te owaza yo resevwa yon doz sel nan Xofluza (doz ki baze sou pwa ko) oswa plasebo kom yon mezi yo anpeche enfliyanza. Pwen prensipal la se te pou evalye pwoposyon matye ki teste pozitif pou viris enfliyanza, te gen lafyev, e li te gen youn oubyen plis sentom respiratwa pandan peryod obsevasyon an depi jou 1-10.

Rezilta yo te montre ke nan mitan matye sante ki gen manm fanmi yo te enfliyanza, yon sel administrasyon nan Xofluza te gen yon efe enpotan sou anpeche enfeksyon grip ak siyifikativman redwi risk pou yo enfliyanse pa 86%. Done yo espesifik yo: Konpare ak gwoup la plase, pwoposyon an nan matye ak enfliyanza enfeksyon nan gwoup la Xofluza te siyifikativman redwi (pwoposyon an nan matye ak enfluenza viris enfeksyon, lafyev ak lot sentom grip pandan peryod obsevasyon 10-jou a: 1.9% vs 13.6% , P<0.0001). regardless="" of="" the="" influenza="" a="" subtype,="" the="" therapeutic="" benefit="" of="" xofluza="" is="" still="" statistically="" significant="" compared="" with="" placebo="" (h1n1="" subtype:="" 1.1%="" vs="" 10.6%,="" p="0.0023;" h3="" subtype:="" 2.8%="" vs="" 17.5%,="" p="" ＜0.0001).="" in="" addition,="" this="" situation="" was="" also="" observed="" in="" household="" contacts="" with="" a="" higher="" risk="" of="" influenza-related="" complications="" (2.2%="" vs="" 15.4%,="" p="0.0435)" and="" children="" under="" 12="" years="" of="" age="" (4.2%="" vs="" 15.5%,="" p="0.0339)." these="" patients="" are="" more="" likely="" to="" get="" flu.="" the="" study="" also="" showed="" that="" even="" with="" fewer="" flu="" criteria="" (proportion="" of="" participants="" with="" flu,="" fever,="" or="" one="" or="" more="" respiratory="" symptoms)="" applied,="" xofluza="" significantly="" reduced="" the="" risk="" of="" flu="" for="" family="" members="" by="" 76%="" compared="" with="" placebo="" (="" 3%="" vs="" 22.4%,=""><0.0001). in="" the="" study,="" the="" safety="" of="" xofuza="" was="" comparable="" to="" that="" of="" placebo,="" with="" an="" adverse="" event="" rate="" of="" 22.2%="" in="" the="" xofuza="" group="" and="" 20.5%="" in="" the="" placebo="" group.="" xofuza="" has="" no="" reports="" of="" serious="" adverse="">