NgoLwesihlanu, ngoNovemba 05, 2021 - 06:45am
I-PAXLOVID™ (PF-07321332; i-ritonavir) yafunyaniswa yehlisa umngcipheko wokulaliswa esibhedlele okanye wokusweleka ngama-89% xa kuthelekiswa ne-placebo kubantu abadala abangalaliswanga emngciphekweni omkhulu abane-COVID-19.
Kulo lonke uphononongo lwabemi ngoSuku lwe-28, akukho kufa kwaxelwa kwizigulana ezifumene i-PAXLOVID™ xa kuthelekiswa nokufa kwe-10 kwizigulana ezifumene i-placebo.
I-Pfizer iceba ukungenisa idatha njengenxalenye yokungeniswa kwayo okuqhubekayo kwi-US FDA ye-Emergency Use Authorization (EUA) ngokukhawuleza.
I-NEW YORK-(I-WIRE YOSHISHINO)- Pfizer Inc. (NYSE: PFE) namhlanje ibhengeze inoveli yayo yophando ye-COVID-19 yomlomo we-antiviral, i-PAXLOVID™, inciphise kakhulu ukulaliswa esibhedlele kunye nokufa, ngokusekwe kuhlalutyo lwethutyana lweSigaba 2/3 EPIC- I-HR (Vavaluation of Protease Inhibition for COVID-19 in High-Risk Patients) uphononongo olungacwangciswanga, olungaboni kabini lwabaguli abangalaliswanga esibhedlele abane-COVID-19, abasemngciphekweni omkhulu wokuqhubela phambili kwisigulo esiqatha.Uhlalutyo lwexeshana olucwangcisiweyo lubonise ukuncipha kwama-89% kumngcipheko wokulaliswa esibhedlele okunxulumene ne-COVID-19 okanye ukufa naso nasiphi na isizathu xa kuthelekiswa ne-placebo kwizigulana ezinyangwa kwiintsuku ezintathu zokuqala kweempawu (isiphelo sokuqala);I-0.8% yezigulane ezifumene i-PAXLOVID ™ zifakwe esibhedlele ngoSuku lwe-28 ngokulandela i-randomization (3/389 esibhedlele ngaphandle kokufa), xa kuthelekiswa ne-7.0% yezigulane ezifumene i-placebo kwaye zalaliswa esibhedlele okanye zafa (27/385 esibhedlele kunye nokufa kwe-7 elandelayo).Ukubaluleka kwamanani ezi ziphumo bekuphezulu (p<0.0001).Ukwehliswa okufanayo esibhedlele okunxulumene ne-COVID-19 okanye ukufa kwaphawulwa kwizigulana ezinyangwa kwiintsuku ezintlanu zokuqala kweempawu;I-1.0% yezigulane ezifumene i-PAXLOVID ™ zifakwe esibhedlele ngoSuku lwe-28 ngokulandela i-randomization (i-6 / 607 esibhedlele, ngaphandle kokufa), xa kuthelekiswa ne-6.7% yezigulane ezifumene i-placebo (41 / 612 esibhedlele kunye nokufa kwe-10 elandelayo), kunye nezibalo eziphezulu. ukubaluleka (p <0.0001).Kulo lonke uphononongo lwabemi ngoSuku lwe-28, akukho kufa kwaxelwa kwizigulane ezifumene i-PAXLOVID™ xa kuthelekiswa ne-10 (1.6%) yokufa kwizigulane ezifumene i-placebo.
Kwingcebiso yeKomiti ezimeleyo yokuHlola iDatha kunye nokubonisana ne-US Food and Drug Administration (FDA), i-Pfizer iya kuyeka ukubhalisa ngakumbi kwisifundo ngenxa yokusebenza kakuhle okubonakaliswe kwezi ziphumo kunye nezicwangciso zokungenisa idatha njengenxalenye yayo. ukuhanjiswa okuqhubekayo kwi-US FDA yoGunyaziso lokuSebenzisa oluNgxamisekileyo (EUA) ngokukhawuleza.
“Iindaba zanamhlanje zitshintsha ngokwenene kwiinzame zehlabathi zokunqanda ukonakala kwesi sifo.Ezi datha zibonisa ukuba umgqatswa wethu womlomo we-antiviral, ukuba uvunyiwe okanye ugunyaziswe ngabasemagunyeni, unamandla okusindisa ubomi bezigulana, anciphise ubukhali bosulelo lwe-COVID-19, kwaye aphelise ukuya kutsho kwisithoba kwabalishumi esibhedlele, utshilo u-Albert Bourla, USihlalo kunye neGosa eliLawulayo eliyiNtloko, uPfizer."Ngenxa yefuthe eliqhubekayo lehlabathi le-COVID-19, siye sahlala sigxile kwisayensi kwaye sizalisekisa uxanduva lwethu lokunceda iinkqubo zempilo kunye namaziko kwihlabathi liphela ngelixa siqinisekisa ukufikelela ngokulinganayo nokubanzi ebantwini kuyo yonke indawo."
Ukuba ivunyiwe okanye igunyazisiwe, i-PAXLOVID™, ephuma kwiilabhoratri ze-Pfizer, iya kuba yeye-antiviral yokuqala yomlomo yohlobo lwayo, eyilwe ngokukodwa i-SARS-CoV-2-3CL protease inhibitor.Ekugqityweni ngempumelelo kwentsalela yenkqubo yophuhliso lweklinikhi ye-EPIC kwaye ngokuxhomekeke ekuvunyweni okanye ekugunyazisweni, inokumiselwa ngokubanzi njengonyango lwasekhaya ukunceda ukunciphisa ubunzima bokugula, ukulaliswa esibhedlele, kunye nokufa, kunye nokunciphisa amathuba okusuleleka. emva kokuvezwa, phakathi kwabantu abadala.Ibonakalise umsebenzi onamandla we-antiviral in vitro ngokuchasene nokujikeleza okwahluka okuxhalabisayo, kunye nezinye ii-coronavirus ezaziwayo, ezibonisa amandla ayo njengonyango kwiintlobo ezininzi zosulelo lwe-coronavirus.
"Sonke ePfizer sinebhongo elimangalisayo ngezazinzulu zethu, eziye zayila kwaye zaphuhlisa le molekyuli, zisebenza ngokungxamisekileyo ukunceda ukunciphisa ifuthe lesi sifo sitshabalalisayo kwizigulana nakuluntu lwazo," utshilo uMikael Dolsten, MD, PhD., IGosa lezeNzululwazi eliyiNtloko kunye noMongameli, uPhando lwehlabathi lonke, uPhuhliso kunye noNyango lwePfizer."Sibulela kuzo zonke izigulana, abaphandi, kunye neendawo kwihlabathi liphela ezithathe inxaxheba kolu vavanyo lweklinikhi, zonke zinenjongo enye yokuzisa impumelelo yonyango lomlomo ukunceda ukulwa i-COVID-19."
Uphononongo lweSigaba 2/3 se-EPIC-HR luqale ukubhaliswa ngoJulayi ka-2021. Isigaba sesi-2/3 se-EPIC-SR (uVavanyo lwe-Protease Inhibition ye-COVID-19 kwi-Standard-Risk Patients) kunye ne-EPIC-PEP (Vavaluation of Protease Inhibition for COVID- I-19 kwizifundo ze-Post-Exposure Prophylaxis), ezaqala ngo-Agasti noSeptemba 2021 ngokulandelanayo, azizange zibandakanywe kolu hlalutyo lwethutyana kwaye ziyaqhubeka.
Malunga neSigaba se-2/3 soPhando lweThutyana lwe-EPIC-HR
Uhlalutyo oluphambili lweseti yedatha yesikhashana ivavanywe idatha evela kubantu abadala abayi-1219 ababhaliswe ngoSeptemba 29, 2021. Ngexesha lesigqibo sokuyeka ukukhangela izigulane, ukubhaliswa kwakukwi-70% yezigulane ezicwangcisiweyo ze-3,000 ezivela kwiindawo zovavanyo lwekliniki kulo lonke elaseNyakatho kunye UMzantsi Merika, iYurophu, iAfrika, kunye neAsia, kunye ne-45% yezigulana ezihlala eUnited States.Abantu ababhalisiweyo babenoxilongo oluqinisekisiweyo lwaselabhoratri losulelo lwe-SARS-CoV-2 kwisithuba seentsuku ezintlanu ezineempawu ezithambileyo ukuya kweziphakathi kwaye kwafuneka ukuba ubuncinci babe neempawu okanye imeko yezempilo ephantsi ehambelana nomngcipheko owongeziweyo wokugula kakhulu kwi-COVID. -19.Isigulane ngasinye sasingenamkhethe (1: 1) ukufumana i-PAXLOVID ™ okanye i-placebo ngomlomo rhoqo kwiiyure ze-12 iintsuku ezintlanu.
Malunga neSigaba se-2/3 seDatha yoKhuseleko lwe-EPIC-HR
Ukuphononongwa kwedatha yokhuseleko kubandakanya iqela elikhulu lezigulane ze-1881 kwi-EPIC-HR, idatha yazo yayifumaneka ngexesha lokuhlalutya.Iziganeko ezimbi ezibangelwa unyango zithelekiseka phakathi kwe-PAXLOVID™ (19%) kunye ne-placebo (21%), uninzi lwazo lwalunobunzima obuncinci.Phakathi kwezigulane ezinokuvandlakanywa kunyango-iziganeko ezimbi eziphuthumayo, zimbalwa iziganeko ezimbi kakhulu (1.7% vs. 6.6%) kunye nokuyekwa kweyeza lokufunda ngenxa yeziganeko ezimbi (2.1% vs. 4.1%) zabonwa kwizigulane ezifakwe kwi-PAXLOVID ™ xa kuthelekiswa placebo, ngokulandelanayo.
Malunga ne-PAXLOVID™ (PF-07321332; ritonavir) kunye neNkqubo yoPhuhliso ye-EPIC
I-PAXLOVID ™ lunyango lophando lwe-SARS-CoV-2 protease inhibitor, eyenzelwe ngokukodwa ukuba ilawulwe ngomlomo ukuze ibe nokumiselwa kuphawu lokuqala losulelo okanye ekuqaleni ukwazi ukuba sesichengeni, okunokunceda izigulana ukuba ziphephe ukugula kakhulu okunokukhokelela. ukuya esibhedlele nokufa.I-PF-07321332 yenzelwe ukuvala umsebenzi we-SARS-CoV-2-3CL protease, i-enzyme ekufuneka iphindwe kabini yi-coronavirus.Ulawulo-ndawonye kunye nedosi ephantsi ye-ritonavir inceda ukucothisa imetabolism, okanye ukonakala, ye-PF-07321332 ukuze ihlale isebenza emzimbeni ixesha elide kwindawo ephezulu ukunceda ukulwa intsholongwane.
PF-07321332 inqanda ukuphindaphinda kwentsholongwane kwinqanaba elaziwa ngokuba yiproteolysis, eyenzeka phambi kokuphindaphinda kwe-RNA yentsholongwane.Kwizifundo zangaphambili, i-PF-07321332 ayizange ibonise ubungqina bokusebenzisana kwe-DNA ye-mutagenic.
U-Pfizer uqalise uphononongo lwe-EPIC-HR ngoJulayi ka-2021 kulandela iziphumo zolingo lwezonyango oluncomekayo lweSigaba soku-1 kwaye uyaqhubeka nokuvavanya i-antiviral yophando kumaphononongo ongezelelweyo e-EPIC.Ngo-Agasti ka-2021, uPfizer waqalisa iSigaba 2/3 se-EPIC-SR (uVavanyo lwe-Protease Inhibition ye-COVID-19 kwi-Standard-Risk Patients), ukuvavanya ukusebenza nokhuseleko kwizigulana ezinofunyaniso oluqinisekisiweyo losulelo lwe-SARS-CoV-2 kumngcipheko oqhelekileyo (oko kukuthi, umngcipheko ophantsi wokulaliswa esibhedlele okanye wokusweleka).I-EPIC-SR ibandakanya iqela lezigulana ezigonyiweyo ezinophawu losulelo lwe-COVID-19 kwaye ezinomngcipheko wokugula kakhulu.NgoSeptemba, uPfizer uqalise iSigaba 2/3 se-EPIC-PEP (uVavanyo lwe-Protease Inhibition ye-COVID-19 kwi-Post-Exposure Prophylaxis) ukuvavanya ukusebenza nokhuseleko kubantu abadala abachatshazelwe yi-SARS-CoV-2 lilungu losapho.
Ngolwazi oluthe vetshe ngeEPIC iSigaba sesi-2/3 solingo lwezonyango lwe-PAXLOVID™, ndwendwela Clinictrials.gov.
Malunga nokuZibophelela kwePfizer kuFikelelo oluLinganayo
U-Pfizer uzibophelele ekusebenzeleni ukufikelela ngokulinganayo kwi-PAXLOVID™ kubo bonke abantu, ejonge ukunikezela ngonyango olukhuselekileyo nolusebenzayo lwe-antiviral ngokukhawuleza kwaye ngexabiso elifikelelekayo.Ukuba umgqatswa wethu uphumelele, ngexesha lo bhubhani, iPfizer iya kubonelela ngonyango lonyango lonyango lonyango lomlomo lophando ngokusebenzisa indlela yokubeka amaxabiso ngokwenqanaba elisekwe kwinqanaba lengeniso yelizwe ngalinye ukukhuthaza ukulingana kofikelelo kwihlabathi liphela.Amazwe anengeniso ephezulu kunye nephezulu-phakathi aya kuhlawula ngaphezulu kwamazwe anengeniso ephantsi.Inkampani ingene kwizivumelwano zokuthenga kwangaphambili kunye namazwe amaninzi kwaye ikuthethathethwano namanye aliqela.I-Pfizer nayo iqalile kwaye iya kuqhubeka ukutyala ukuya kutsho malunga ne-1 yeebhiliyoni zeerandi ukuxhasa ukwenziwa kunye nokusasazwa kolu nyango lophando, kubandakanywa nokuphonononga iinketho ezinokubakho zekhontrakthi yokuvelisa ukunceda ekuqinisekiseni ukufikelela kumazwe anengeniso ephantsi kunye nephakathi, kusalindwe ugunyaziso lolawulo.
Inkampani isebenzela ukuqinisekisa ukufikelela kwenoveli yomgqatswa we-antiviral kwabo baswele kakhulu kwihlabathi liphela, kulindelwe iziphumo zovavanyo oluyimpumelelo kunye nokwamkelwa okusemthethweni.
Ixesha lokuposa: Nov-19-2021