Lachisanu, Novembara 05, 2021 - 06:45 am
PAXLOVID™ (PF-07321332; ritonavir) idapezeka kuti imachepetsa chiwopsezo chogonekedwa m'chipatala kapena kufa ndi 89% poyerekeza ndi placebo mwa akuluakulu omwe sali m'chipatala omwe ali pachiwopsezo chachikulu cha COVID-19.
Pachiwerengero chonse chowerengera kudzera pa Tsiku 28, palibe imfa yomwe idanenedwa mwa odwala omwe adalandira PAXLOVID™ poyerekeza ndi kufa 10 mwa odwala omwe adalandira placebo.
Pfizer ikukonzekera kutumiza zidziwitsozo ngati gawo la zomwe akupitilirabe ku US FDA for Emergency Use Authorization (EUA) posachedwa
NEW YORK-(BUSINESS WIRE)- Pfizer Inc. (NYSE: PFE) lero yalengeza buku lake lofufuza za COVID-19, PAXLOVID™, lachepetsa kwambiri kugona m'chipatala ndi imfa, kutengera kuwunika kwakanthawi kwa Gawo 2/3 EPIC- Kafukufuku wa HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) kafukufuku wachisawawa, wakhungu kawiri wa odwala omwe sanagonekedwe kuchipatala omwe ali ndi COVID-19, omwe ali pachiwopsezo chachikulu chodwala kwambiri.Kuwunika kwakanthawi kochepa kunawonetsa kuchepa kwa 89% kwa chiwopsezo chogonekedwa m'chipatala chokhudzana ndi COVID-19 kapena kufa chifukwa chilichonse poyerekeza ndi placebo mwa odwala omwe adalandira chithandizo mkati mwa masiku atatu chiyambireni zizindikiro (mapeto oyambira);0.8% ya odwala omwe adalandira PAXLOVID ™ adagonekedwa m'chipatala kudzera pa Tsiku la 28 kutsatira mosasinthika (3/389 m'chipatala popanda kufa), poyerekeza ndi 7.0% ya odwala omwe adalandira placebo ndipo adagonekedwa m'chipatala kapena kumwalira (27/385 m'chipatala ndi 7 kufa pambuyo pake).Kufunika kwachiwerengero chazotsatirazi kunali kwakukulu (p<0.0001).Kuchepetsa kofananirako m'chipatala kapena imfa yokhudzana ndi COVID-19 kudawonedwa mwa odwala omwe adalandira chithandizo mkati mwa masiku asanu chiyambireni zizindikiro;1.0% ya odwala omwe adalandira PAXLOVID ™ adagonekedwa m'chipatala kudzera pa Tsiku 28 kutsatira mosasintha (6/607 m'chipatala, osamwalira), poyerekeza ndi 6.7% ya odwala omwe adalandira placebo (41/612 m'chipatala ndi kufa 10 kotsatira), ndi ziwerengero zambiri. tanthauzo (p<0.0001).Pachiwerengero chonse chowerengera kudzera pa Tsiku 28, palibe kufa komwe kunanenedwa mwa odwala omwe adalandira PAXLOVID™ poyerekeza ndi 10 (1.6%) omwe amafa mwa odwala omwe adalandira placebo.
Paupangiri wa komiti yodziyimira payokha yowunika za data komanso mogwirizana ndi US Food and Drug Administration (FDA), Pfizer asiya kulembetsa nawo kafukufukuyu chifukwa chakuchita bwino komwe kwawonetsedwa pazotsatirazi ndikukonzekera kutumiza deta ngati gawo la kafukufukuyu. kugonjera kosalekeza ku US FDA for Emergency Use Authorization (EUA) posachedwa.
"Nkhani zamasiku ano zasintha kwambiri ntchito zapadziko lonse lapansi zoletsa kuwononga kwa mliriwu.Izi zikusonyeza kuti munthu wathu wapakamwa, ngati avomerezedwa kapena kuvomerezedwa ndi oyang'anira, ali ndi kuthekera kopulumutsa miyoyo ya odwala, kuchepetsa kuopsa kwa matenda a COVID-19, ndikuchotsa zipatala zisanu ndi zinayi mwa khumi," adatero Albert Bourla, Chairman ndi Chief Executive Officer, Pfizer."Poganizira momwe COVID-19 ikupitilirabe padziko lonse lapansi, takhala tikuyang'ana kwambiri zasayansi ndikukwaniritsa udindo wathu wothandizira zaumoyo ndi mabungwe padziko lonse lapansi ndikuwonetsetsa kuti anthu ali ndi mwayi wopezeka paliponse."
Ngati itavomerezedwa kapena kuvomerezedwa, PAXLOVID™, yomwe idachokera kumalo opangira ma labotale a Pfizer, ingakhale yoyamba yapakamwa yamtundu wake, yopangidwa makamaka ndi SARS-CoV-2-3CL protease inhibitor.Mukamaliza bwino pulogalamu yotsala ya EPIC yachitukuko chachipatala ndikuvomerezedwa kapena kuvomerezedwa, ikhoza kuperekedwa momveka bwino ngati chithandizo chapakhomo chothandizira kuchepetsa kuopsa kwa matenda, kugona m'chipatala, ndi imfa, komanso kuchepetsa mwayi wa matenda. kutsatira kukhudzana, pakati pa akuluakulu.Zawonetsa zochitika zamphamvu za antiviral in vitro motsutsana ndi kufalikira kwamitundu yosiyanasiyana, komanso ma coronavirus ena odziwika, ndikuwonetsa kuthekera kwake ngati njira yochizira mitundu ingapo ya matenda a coronavirus.
"Tonsefe ku Pfizer timanyadira kwambiri asayansi athu, omwe adapanga ndikupanga molekyulu iyi, akugwira ntchito mwachangu kwambiri kuti achepetse kukhudzidwa kwa matendawa kwa odwala ndi madera awo," atero a Mikael Dolsten, MD, PhD., Chief Scientific Officer ndi Purezidenti, Worldwide Research, Development and Medical of Pfizer."Ndife othokoza kwa odwala onse, ofufuza, ndi masamba padziko lonse lapansi omwe adachita nawo mayeso azachipatalawa, onse ndi cholinga chimodzi chokhazikitsa chithandizo cham'kamwa chothandizira kuthana ndi COVID-19."
Kafukufuku wa Phase 2/3 EPIC-HR anayamba kulembetsa mu July 2021. The Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) ndi EPIC-PEP (Evaluation of Protease Inhibition for COVID- 19 mu maphunziro a Post-Exposure Prophylaxis), omwe adayamba mu Ogasiti ndi Seputembala 2021 motsatana, sanaphatikizidwe pakuwunika kwakanthawi kumeneku ndipo akupitilira.
Za Gawo 2/3 EPIC-HR Study Interim Analysis
Kusanthula kwakukulu kwa deta yanthawi yochepa kunayesedwa deta kuchokera kwa akuluakulu a 1219 omwe adalembedwa ndi September 29, 2021. Pa nthawi ya chigamulo chosiya kulemba odwala, kulembetsa kunali 70% mwa odwala 3,000 omwe anakonzedwa kuchokera kumalo oyesera zachipatala kudutsa kumpoto ndi South America, Europe, Africa, ndi Asia, ndi 45% ya odwala omwe ali ku United States.Anthu omwe adalembetsa adazindikira kuti ali ndi matenda a SARS-CoV-2 mu labotale mkati mwa masiku asanu okhala ndi zizindikiro zocheperako komanso zocheperako ndipo amafunikira kukhala ndi chikhalidwe chimodzi kapena vuto lomwe limakhudzana ndi chiopsezo chotenga matenda oopsa kuchokera ku COVID. -19.Wodwala aliyense adasinthidwa (1: 1) kuti alandire PAXLOVID™ kapena placebo pamlomo maola 12 aliwonse kwa masiku asanu.
Za Gawo 2/3 EPIC-HR Study Safety Data
Kuwunika kwa deta yachitetezo kunaphatikizapo gulu lalikulu la odwala 1881 ku EPIC-HR, omwe deta yawo inalipo panthawi ya kusanthula.Zowopsa zomwe zidachitika pakuchiza zinali zofanana pakati pa PAXLOVID ™ (19%) ndi placebo (21%), ambiri mwa iwo anali ofatsa kwambiri.Pakati pa odwala omwe amayesedwa chifukwa cha zovuta zomwe zachitika mwadzidzidzi, zochitika zochepa kwambiri (1.7% vs. 6.6%) ndi kusiya kugwiritsa ntchito mankhwala ophunzirira chifukwa cha zochitika zovuta (2.1% vs. 4.1%) zinawonedwa mwa odwala omwe amamwa PAXLOVID ™ poyerekeza ndi placebo, motero.
Za PAXLOVID™ (PF-07321332; ritonavir) ndi EPIC Development Programme
PAXLOVID ™ ndi kafukufuku wa SARS-CoV-2 protease inhibitor antiviral therapy, wopangidwa makamaka kuti aziperekedwa pakamwa kuti athe kulembedwa pachizindikiro choyamba cha matenda kapena pozindikira koyamba za kukhudzidwa, zomwe zingathandize odwala kupewa matenda oopsa omwe angawatsogolere. kupita kuchipatala ndi imfa.PF-07321332 idapangidwa kuti iletse ntchito ya SARS-CoV-2-3CL protease, enzyme yomwe coronavirus imayenera kubwereza.Kuwongolera limodzi ndi mlingo wochepa wa ritonavir kumathandizira kuchepetsa kagayidwe, kapena kuwonongeka, kwa PF-07321332 kuti ikhalebe yogwira ntchito mthupi kwa nthawi yayitali kwambiri kuti ithandizire kuthana ndi kachilomboka.
PF-07321332 imalepheretsa kubwereza kwa ma virus pa siteji yotchedwa proteolysis, yomwe imachitika ma virus a RNA asanabwere.M'maphunziro a preclinical, PF-07321332 sinawonetse umboni wa kuyanjana kwa DNA mutagenic.
Pfizer adayambitsa kafukufuku wa EPIC-HR mu Julayi 2021 kutsatira zotsatira zabwino za mayeso achipatala a Gawo 1 ndipo akupitilizabe kuyesa antiviral mu maphunziro owonjezera a EPIC.Mu Ogasiti 2021, Pfizer adayambitsa Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients), kuti aunikire mphamvu ndi chitetezo kwa odwala omwe ali ndi matenda a SARS-CoV-2 omwe ali ndi kachilomboka. pachiwopsezo chokhazikika (mwachitsanzo, pachiwopsezo chochepa chogonekedwa m'chipatala kapena imfa).EPIC-SR imaphatikizapo gulu la odwala omwe ali ndi katemera omwe ali ndi kachilombo koyambitsa matenda a COVID-19 komanso omwe ali ndi ziwopsezo zakudwala kwambiri.Mu Seputembala, Pfizer adayambitsa Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) kuti awunikire kuthandizira komanso chitetezo mwa akulu omwe ali ndi SARS-CoV-2 ndi membala wapakhomo.
Kuti mumve zambiri za mayeso azachipatala a EPIC Phase 2/3 a PAXLOVID™, pitani kuchipatalatrials.gov.
Za Kudzipereka kwa Pfizer pa Kupeza Kwachilungamo
Pfizer yadzipereka kuyesetsa kupeza mwayi wopeza PAXLOVID™ kwa anthu onse, ndi cholinga chopereka chithandizo chamankhwala chotetezeka komanso chothandiza cha antiviral posachedwa komanso pamtengo wotsika mtengo.Ngati ofuna kusankhidwa achita bwino, panthawi ya mliri, Pfizer ipereka chithandizo chathu chamankhwala oletsa ma virus pakamwa pogwiritsa ntchito njira yamitengo yotengera momwe dziko lililonse limapezera kuti alimbikitse mwayi wopezeka padziko lonse lapansi.Mayiko omwe amapeza ndalama zambiri ndi apamwamba apakati adzalipira ndalama zambiri kuposa mayiko omwe amapeza ndalama zochepa.Kampaniyo idachita mapangano ogula pasadakhale ndi mayiko angapo ndipo ikukambirana ndi ena angapo.Pfizer yayambanso ndipo ipitilizabe kuyika ndalama pafupifupi $ 1 biliyoni kuti ithandizire kupanga ndi kugawa chithandizo chofufuzirachi, kuphatikiza kufufuza njira zopangira makontrakitala kuti zithandizire kuwonetsetsa kuti mayiko omwe ali ndi ndalama zochepa komanso apakati, akudikirira chilolezo.
Kampaniyo ikuyesetsa kuti iwonetsetse mwayi wopezeka kwa omwe akufunika kwambiri padziko lonse lapansi, podikirira zotsatira zoyeserera komanso kuvomerezedwa ndi malamulo.
Nthawi yotumiza: Nov-19-2021