NgoLwesihlanu, Novemba 05, 2021 - 06:45am
I-PAXLOVID™ (PF-07321332; ritonavir) itholwe yehlisa ubungozi bokulaliswa esibhedlela noma ukufa ngo-89% uma kuqhathaniswa ne-placebo kubantu abadala abangalaliswa engcupheni enkulu abane-COVID-19.
Ocwaningweni oluphelele ngoSuku lwama-28, akukho kufa okubikwe ezigulini ezithole i-PAXLOVID™ uma kuqhathaniswa nokufa kwe-10 ezigulini ezithole i-placebo.
I-Pfizer ihlela ukuhambisa idatha njengengxenye yokuthunyelwa kwayo okuqhubekayo ku-US FDA ye-Emergency Use Authorization (EUA) ngokushesha ngangokunokwenzeka.
I-NEW YORK–(BUSINESS WIRE)- Pfizer Inc. (NYSE: PFE) namuhla imemezele inoveli yayo yophenyo ye-COVID-19 oral antiviral, i-PAXLOVID™, inciphise kakhulu ukulaliswa esibhedlela nokufa, ngokusekelwe ekuhlaziyeni kwesikhashana kweSigaba 2/3 EPIC- I-HR (Ukuhlola Ukuvinjelwa Kwe-Protease kwe-COVID-19 Ezigulini Ezisengozini Ephezulu) ucwaningo olungahleliwe, olungaboni kabili lweziguli zabantu abadala ezingalaliswa esibhedlela ezine-COVID-19, ezisengozini enkulu yokudlulela ekuguleni okubi kakhulu.Ukuhlaziywa kwesikhashana okuhleliwe kubonise ukwehla okungama-89% engcupheni yokulaliswa esibhedlela okuhlobene ne-COVID-19 noma ukufa nganoma iyiphi imbangela uma kuqhathaniswa ne-placebo ezigulini ezelashwa zingakapheli izinsuku ezintathu ziqale izimpawu (isiphetho sokuqala);U-0.8% weziguli ezithole i-PAXLOVID ™ zalaliswa esibhedlela ngosuku lwama-28 kulandela ukungahleliwe (3/389 esibhedlela ngaphandle kokufa), uma kuqhathaniswa no-7.0% weziguli ezathola i-placebo futhi zalaliswa esibhedlela noma zashona (27/385 esibhedlela nokufa okuyi-7 okwalandela).Ukubaluleka kwezibalo kwale miphumela bekuphezulu (p<0.0001).Ukwehliswa okufanayo kokulaliswa esibhedlela okuhlobene ne-COVID-19 noma ukufa kwabonwa ezigulini ezelashwa zingakapheli izinsuku ezinhlanu ziqale izimpawu;I-1.0% yeziguli ezithole i-PAXLOVID ™ zalaliswa esibhedlela ngosuku lwama-28 kulandela ukungahleliwe (6/607 esibhedlela, ngaphandle kokufa), uma kuqhathaniswa ne-6.7% yeziguli ezithole i-placebo (41/612 esibhedlela nokufa kwe-10 okwalandela), ngezibalo eziphezulu. ukubaluleka (p<0.0001).Ocwaningweni oluphelele ngoSuku lwama-28, akukho kufa okubikwe ezigulini ezithole i-PAXLOVID™ uma kuqhathaniswa nokufa kwe-10 (1.6%) ezigulini ezithole i-placebo.
Ngokwesincomo seKomidi elizimele Lokuqapha Idatha kanye nokubonisana ne-US Food and Drug Administration (FDA), i-Pfizer izoyeka ukubhalisa ocwaningweni ngenxa yokusebenza ngempumelelo okukhulu okuboniswe kule miphumela kanye nezinhlelo zokuhambisa idatha njengengxenye yocwaningo. ukuhanjiswa okuqhubekayo okuqhubekayo ku-US FDA Yokugunyazwa Kokusetshenziswa Kwezimo Eziphuthumayo (EUA) ngokushesha ngangokunokwenzeka.
“Izindaba zanamuhla ziwushintsho lwangempela emizamweni yomhlaba wonke yokunqanda ukucekelwa phansi kwalolu bhubhane.Le mininingwane iphakamisa ukuthi umuntu ozomela i-antiviral ngomlomo, uma egunyazwe noma egunyazwe yiziphathimandla ezilawulayo, unamandla okusindisa izimpilo zeziguli, anciphise ubungozi bokutheleleka nge-COVID-19, futhi aqedele ukulaliswa esibhedlela okufika kwabayisishiyagalolunye kwabayishumi, ”kusho u-Albert Bourla, USihlalo kanye noMphathi Omkhulu, uPfizer."Uma kubhekwa umthelela oqhubekayo womhlaba wonke we-COVID-19, sisagxile kwisayensi futhi sifeza umthwalo wethu wemfanelo wokusiza izinhlelo zezempilo nezikhungo emhlabeni wonke ngenkathi siqinisekisa ukufinyelela okulinganayo nokubanzi kubantu yonke indawo."
Uma igunyaziwe noma igunyazwa, i-PAXLOVID™, eqhamuke kulabhorethri yakwa-Pfizer, izoba isinqamuleli somlomo sokuqala sohlobo lwayo, i-SARS-CoV-2-3CL protease inhibitor eklanywe ngokukhethekile.Lapho sekuphothulwe ngempumelelo ingxenye esele yohlelo lokuthuthukiswa komtholampilo we-EPIC futhi kuncike ekuvunyweni noma ekugunyazweni, kungase kubekwe kabanzi njengokwelashwa kwasekhaya ukuze kuncishiswe ukugula, ukulaliswa esibhedlela, nokufa, kanye nokunciphisa amathuba okutheleleka. ukuchayeka okulandelayo, phakathi kwabantu abadala.Ikhombise umsebenzi onamandla we-antiviral in vitro ngokumelene nokujikeleza okuhlukahlukene kokukhathazeka, kanye namanye ama-coronavirus aziwayo, ephakamisa amandla ayo njengendlela yokwelapha izinhlobo eziningi zokutheleleka nge-coronavirus.
"Sonke kwa-Pfizer siyaziqhenya ngendlela emangalisayo ngososayensi bethu, abaklama futhi bathuthukisa le molecule, besebenza ngokuphuthuma kakhulu ukusiza ukwehlisa umthelela walesi sifo esibhubhisayo ezigulini nasemiphakathini yazo," kusho uMikael Dolsten, MD, PhD., Isikhulu Esiyinhloko Sezesayensi kanye noMongameli, Ucwaningo Lomhlaba Wonke, Ukuthuthukiswa kanye Nokwelashwa kwe-Pfizer."Sibonga zonke iziguli, abaphenyi, kanye nezindawo emhlabeni jikelele ezibambe iqhaza kulolu cwaningo lomtholampilo, konke ngenhloso efanayo yokuletha impumelelo yokwelapha ngomlomo ukusiza ukulwa ne-COVID-19."
Ucwaningo lweSigaba 2/3 se-EPIC-HR luqale ukubhaliswa ngoJulayi 2021. Isigaba sesi-2/3 se-EPIC-SR (Ukuhlolwa Kwe-Protease Inhibition ye-COVID-19 ku-Standard-Risk Patients) kanye ne-EPIC-PEP (Ukuhlola Ukuvinjelwa Kwe-Protease kwe-COVID- Ezingu-19 ezifundweni ze-Post-Exposure Prophylaxis), ezaqala ngo-August no-September 2021 ngokulandelana kwazo, azifakwanga kulokhu kuhlaziywa kwesikhashana futhi ziyaqhubeka.
Mayelana Nokuhlaziywa Kwesikhashana Kocwaningo Lwesigaba 2/3 EPIC-HR
Ukuhlaziywa okuyinhloko kwesethi yedatha yesikhashana kwahlaziywa idatha evela kubantu abadala abangu-1219 ababebhaliswe ngoSepthemba 29, 2021. Ngesikhathi sesinqumo sokuyeka ukuqasha iziguli, ukubhaliswa kwakuku-70% weziguli ezihleliwe ezingu-3,000 ezivela ezindaweni zokuhlolwa kwemitholampilo kulo lonke elaseNyakatho kanye. INingizimu Melika, iYurophu, i-Afrika, ne-Asia, nama-45% eziguli ezitholakala e-United States.Abantu ababhalisiwe babenokuxilongwa okuqinisekisiwe elabhorethri yokutheleleka kwe-SARS-CoV-2 phakathi nenkathi yezinsuku ezinhlanu enezimpawu ezithambile kuya kwezimaphakathi futhi kwakudingeka ukuthi okungenani babe nesici esisodwa noma isimo sezempilo esihlobene nengozi eyengeziwe yokuthola ukugula okunzima okuvela ku-COVID. -19.Isiguli ngasinye sasihlelwe ngokungahleliwe (1:1) ukuze sithole i-PAXLOVID™ noma i-placebo ngomlomo njalo emahoreni ayi-12 izinsuku ezinhlanu.
Mayelana Nesigaba 2/3 Sedatha Yokuphepha Kocwaningo ye-EPIC-HR
Ukubuyekezwa kwedatha yokuphepha kufaka phakathi iqoqo elikhulu leziguli ze-1881 ku-EPIC-HR, idatha yazo yayitholakala ngesikhathi sokuhlaziywa.Izehlakalo ezimbi eziqhamuka ekwelapheni ziqhathaniswe phakathi kwe-PAXLOVID™ (19%) ne-placebo (21%), iningi lazo ebezinokuqina okuncane.Phakathi kweziguli ezingahlolela izehlakalo ezimbi eziqhamuka ekwelapheni, izehlakalo ezimbi ezimbi kakhulu (1.7% vs. 6.6%) kanye nokuyekiswa kwesidakamizwa esifundwayo ngenxa yezehlakalo ezimbi (2.1% vs. 4.1%) kubonwe ezigulini ezidose i-PAXLOVID™ uma kuqhathaniswa ne i-placebo, ngokulandelana.
Mayelana ne-PAXLOVID™ (PF-07321332; ritonavir) kanye Nohlelo Lokuthuthukiswa Kwe-EPIC
I-PAXLOVID™ iyi-surgational therapy ye-SARS-CoV-2 protease inhibitor antiviral, eklanyelwe ngokukhethekile ukuthi inikezwe ngomlomo ukuze ikwazi ukunikezwa lapho iqala ukutheleleka noma lapho iqala ukuqaphela ukuchayeka, engase isize iziguli zigweme ukugula okunzima okungaholela. ukuya esibhedlela nokufa.I-PF-07321332 yakhelwe ukuvimba umsebenzi we-SARS-CoV-2-3CL protease, i-enzyme okudingeka i-coronavirus iphindaphinde.Ukuphatha ngokubambisana nethamo eliphansi le-ritonavir kusiza ukubambezela ukumetabolism, noma ukuwohloka, kwe-PF-07321332 ukuze ihlale isebenza emzimbeni isikhathi eside ekugxilweni okuphezulu ukusiza ukulwa naleli gciwane.
I-PF-07321332 ivimbela ukuphindaphinda kwegciwane esigabeni esaziwa ngokuthi i-proteolysis, esenzeka ngaphambi kokuphindaphinda kwe-RNA yegciwane.Ezifundweni ze-preclinical, i-PF-07321332 ayizange ibonise ubufakazi bokusebenzisana kwe-mutagenic DNA.
I-Pfizer iqale ucwaningo lwe-EPIC-HR ngoJulayi 2021 kulandela imiphumela yokuhlolwa yomtholampilo yeSigaba 1 futhi iyaqhubeka nokuhlola isinqamuleli-gciwane esiphenyayo kwezinye izifundo ze-EPIC.Ngo-Agasti 2021, i-Pfizer yasungula iSigaba 2/3 EPIC-SR (Ukuhlolwa Kwe-Protease Inhibition ye-COVID-19 e-Standard-Risk Patients), ukuhlola ukusebenza kahle nokuphepha ezigulini ezinokuxilongwa okuqinisekisiwe kokutheleleka kwe-SARS-CoV-2 engcupheni evamile (okungukuthi, ingozi ephansi yokulaliswa esibhedlela noma yokufa).I-EPIC-SR ifaka iqoqo leziguli ezigonyiwe ezinokutheleleka okunamandla okuyi-COVID-19 futhi ezinezici engcupheni yokugula okunzima.NgoSepthemba, u-Pfizer waqala iSigaba 2/3 EPIC-PEP (Ukuhlola Ukuvinjelwa Kwe-Protease kwe-COVID-19 ku-Post-Exposure Prophylaxis) ukuze kuhlolwe ukusebenza kahle nokuphepha kubantu abadala abachayeke ku-SARS-CoV-2 yilungu lomndeni.
Ukuze uthole ulwazi olwengeziwe ngezinhlolo zomtholampilo ze-EPIC Isigaba sesi-2/3 se-PAXLOVID™, vakashela i-clinicaltrials.gov.
Mayelana Nokuzibophezela kwe-Pfizer Ekufinyeleleni Ngokulinganayo
I-Pfizer izimisele ukusebenzela ukufinyelela ngokulinganayo ku-PAXLOVID™ kubo bonke abantu, ihlose ukuletha imithi yokwelapha elwa namagciwane ephephile futhi ephumelelayo ngokushesha ngangokunokwenzeka nangenani elithengekayo.Uma umuntu esizongenela ukhetho ephumelela, phakathi nalolu bhubhane, i-Pfizer izohlinzeka ngemithi yethu yophenyo yomlomo ye-antiviral ngokusebenzisa indlela yokubeka amanani esekelwe ezingeni lemali engenayo lezwe ngalinye ukukhuthaza ukulingana kokufinyelela emhlabeni wonke.Amazwe anengeniso ephezulu naphakathi nendawo azokhokha ngaphezu kwamazwe anengeniso ephansi.Inkampani yenze izivumelwano zokuthenga kusenesikhathi namazwe amaningi futhi isezingxoxweni namanye amaningana.I-Pfizer nayo isiqalile futhi izoqhubeka nokutshala imali efinyelela cishe ku-$1 bhiliyoni ukuze isekele ukwenziwa nokusatshalaliswa kwalokhu kwelashwa okuphenywayo, okuhlanganisa nokuhlola izinketho zokukhiqiza izinkontileka ezingaba khona ukusiza ukuqinisekisa ukufinyelela kuwo wonke amazwe anemali engenayo ephansi naphakathi, kusalindwe ukugunyazwa ngokomthetho.
Le nkampani isebenzela ukuqinisekisa ukufinyelela kwenoveli yayo ye-antiviral kulabo abayidinga kakhulu emhlabeni jikelele, kusalindwe imiphumela yesivivinyo esiyimpumelelo kanye nokugunyazwa ngokomthetho.
Isikhathi sokuthumela: Nov-19-2021