Labohlano la la 05 Pulungoana 2021 - 06:45 hoseng
PAXLOVID™ (PF-07321332; ritonavir) e fumanoe e fokotsa kotsi ea ho kena sepetlele kapa lefu ka 89% ha e bapisoa le placebo ho batho ba baholo ba seng ba le kotsing e kholo ea COVID-19.
Palong eohle ea thuto ho fihlela ka Letsatsi la 28, ha ho lefu le tlalehiloeng ho bakuli ba amohetseng PAXLOVID ™ ha ho bapisoa le mafu a 10 ho bakuli ba fumaneng placebo.
Pfizer e rera ho fana ka lintlha e le karolo ea tlhahiso ea eona e tsoelang pele ho US FDA bakeng sa Authorization ea Tšebeliso ea Tšohanyetso (EUA) kapele kamoo ho ka khonehang.
NEW YORK-(BUSINESS WIRE)- Pfizer Inc. (NYSE: PFE) kajeno e phatlalalitse buka ea eona ea lipatlisiso ea COVID-19 oral antiviral, PAXLOVID™, e fokolitse haholo ho kena sepetlele le lefu, ho ipapisitse le tlhahlobo ea nakoana ea Phase 2/3 EPIC- HR (Avaluation of Protease Inhibition for COVID-19 in High-Risk Patients) thuto e sa boneng habeli ea bakuli ba sa kena sepetlele ba nang le COVID-19, ba kotsing e kholo ea ho tsoela pele ho kula haholo.Tlhahlobo ea nakoana e reriloeng e bonts'itse phokotso ea 89% ea kotsi ea ho kena sepetlele kapa lefu le amanang le COVID-19 ka lebaka lefe kapa lefe ha ho bapisoa le placebo ho bakuli ba alafshoang nakong ea matsatsi a mararo ho tloha ha matšoao a qala;0.8% ea bakuli ba fumaneng PAXLOVID ™ ba ile ba kena sepetlele ka Letsatsi la 28 ka mor'a ho etsoa ka mokhoa o sa reroang (3/389 ba kena sepetlele ba se na lefu), ha ba bapisoa le 7.0% ea bakuli ba fumaneng placebo mme ba kena sepetlele kapa ba hlokahala (27/385 sepetlele ka lefu le latelang la 7).Bohlokoa ba lipalo-palo ba liphetho tsena bo ne bo le holimo (p<0.0001).Phokotso e ts'oanang ea ho kena sepetlele kapa lefu le amanang le COVID-19 e ile ea bonoa ho bakuli ba phekoloang nakong ea matsatsi a mahlano ho tloha ha matšoao a qala;1.0% ea bakuli ba amohetseng PAXLOVID ™ ba ile ba kena sepetlele ho fihlela Letsatsi la 28 kamora ho etsoa ka tšohanyetso (6/607 sepetlele, ba se na lefu), ha ba bapisoa le 6.7% ea bakuli ba fumaneng placebo (41/612 sepetlele ka lefu le latelang la 10), ka lipalo-palo tse phahameng. bohlokoa (p<0.0001).Palong ea kakaretso ea thuto ho fihlela ka Letsatsi la 28, ha ho lefu le tlalehiloeng ho bakuli ba amohetseng PAXLOVID ™ ha ho bapisoa le mafu a 10 (1.6%) ho bakuli ba fumaneng placebo.
Ka khothaletso ea Komiti e ikemetseng ea Tlhokomelo ea Lintlha le ka therisano le Tsamaiso ea Lijo le Lithethefatsi ea US (FDA), Pfizer e tla emisa ho ingolisa thutong ka lebaka la katleho e kholo e bonts'itsoeng liphethong tsena le merero ea ho fana ka data e le karolo ea eona. tlhahiso e ntseng e tsoela pele ho US FDA bakeng sa Tumello ea Tšebeliso ea Tšohanyetso (EUA) kapele kamoo ho ka khonehang.
"Litaba tsa kajeno ke phetoho ea 'nete boitekong ba lefats'e ba ho emisa tšenyo ea seoa sena.Lintlha tsena li fana ka maikutlo a hore mokhethoa oa rona oa antiviral, haeba a amohetsoe kapa a lumelletsoe ke balaoli ba tsamaiso, o na le monyetla oa ho pholosa bophelo ba bakuli, ho fokotsa ho teba ha ts'oaetso ea COVID-19, le ho felisa lipetlele tse fihlang ho tse robong ho tse leshome, "ho boletse Albert Bourla, Molula-setulo le Ofisiri e ka Sehloohong ea Phethahatso, Pfizer."Ka lebaka la tšusumetso e tsoelang pele ea lefats'e ea COVID-19, re lutse re tsepamisitse maikutlo ho mahlale le ho phethahatsa boikarabello ba rona ba ho thusa lits'ebeletso tsa bophelo bo botle le litsi lefats'eng ka bophara ha re ntse re netefatsa phihlello e lekanang le e pharaletseng ea batho hohle."
Haeba e amohetsoe kapa e lumelletsoe, PAXLOVID™, e qalileng ka laboratoring ea Pfizer, e tla ba antiviral ea pele ea mofuta oa eona, e leng SARS-CoV-2-3CL protease inhibitor e etselitsoeng ka ho khetheha.Ha ho phethiloe ka katleho karolo e setseng ea lenaneo la ntlafatso ea kliniki ea EPIC mme ho latela tumello kapa tumello, e ka beoa ka mokhoa o pharalletseng e le kalafo ea lapeng ho thusa ho fokotsa bokuli, ho kena sepetlele le lefu, hammoho le ho fokotsa monyetla oa tšoaetso. kgahlamelo e latelang, hara batho ba baholo.E bonts'itse ts'ebetso e matla ea antiviral in vitro khahlano le mefuta e fapaneng ea matšoenyeho, hammoho le li-coronavirus tse ling tse tsebahalang, e fana ka maikutlo a bokhoni ba eona e le pheko bakeng sa mefuta e mengata ea ts'oaetso ea coronavirus.
"Kaofela ha rona ba Pfizer re motlotlo ka bo-ramahlale ba rona, ba thehileng le ho nts'etsapele molek'hule ena, ba sebetsa ka potlako ho thusa ho fokotsa phello ea lefu lena le senyang ho bakuli le sechaba sa bona," ho boletse Mikael Dolsten, MD, PhD., Ofisiri e ka Sehloohong ea Saense le Mopresidente, Lipatlisiso tsa Lefatše Lohle, Nts'etsopele le Bongaka ba Pfizer."Re leboha bakuli bohle, bafuputsi le libaka ho pota lefatše ba nkileng karolo tekong ena ea bongaka, kaofela ka sepheo se le seng sa ho tlisa katleho ea kalafo ea molomo ho thusa ho loants'a COVID-19."
Boithuto ba Mokhahlelo oa 2/3 EPIC-HR bo qalile ho ngolisoa ka Phupu 2021. Phase 2/3 EPIC-SR (Avaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) le EPIC-PEP (Avaluation of Protease Inhibition bakeng sa COVID- 19 lithutong tsa Post-Exposure Prophylaxis), tse qalileng ka Phato le Loetse 2021 ka ho latellana, ha lia kenyelletsoa tlhahlobong ena ea nakoana mme li ntse li tsoela pele.
Mabapi le Mokhahlelo oa 2/3 oa Boithuto ba Nakwana ba EPIC-HR
Tlhahlobo ea mantlha ea data ea nakoana e ile ea hlahloba lintlha tse tsoang ho batho ba baholo ba 1219 ba ngolisitsoeng ka la 29 Loetse 2021. Nakong ea qeto ea ho emisa ho hira bakuli, ngoliso e ne e le ho 70% ea bakuli ba 3,000 ba reriloeng ho tsoa libakeng tsa liteko tsa bongaka ho pholletsa le Leboea le Amerika Boroa, Europe, Afrika le Asia, ka 45% ea bakuli ba United States.Batho ba ngolisitsoeng ba ne ba e-na le tlhahlobo e netefalitsoeng ea laboratori ea ts'oaetso ea SARS-CoV-2 nakong ea matsatsi a mahlano a nang le matšoao a bobebe ho isa ho a leka-lekaneng mme ba ne ba hlokoa hore bonyane ba be le tšobotsi e le 'ngoe kapa boemo ba bongaka bo amanang le kotsi e eketsehileng ea ho tšoaroa ke bokuli bo matla ho tsoa ho COVID. -19.Mokuli e mong le e mong o ne a sa khethoa (1: 1) ho amohela PAXLOVID™ kapa placebo ka molomo lihora tse ling le tse ling tsa 12 ka matsatsi a mahlano.
Mabapi le Lintlha tsa Tšireletseho ea Boithuto ba Mokhahlelo oa 2/3 EPIC-HR
Tlhahlobo ea lintlha tsa polokeho e kenyelelitse sehlopha se seholo sa bakuli ba 1881 ho EPIC-HR, bao lintlha tsa bona li neng li fumaneha nakong ea tlhahlobo.Liketsahalo tse mpe tse hlahang kalafong li ne li bapisoa pakeng tsa PAXLOVID ™ (19%) le placebo (21%), tseo boholo ba tsona li neng li le bobebe ka matla.Har'a bakuli ba ka hlahlojoang bakeng sa liketsahalo tse bohloko tse hlahang kalafo, liketsahalo tse fokolang tse tebileng (1.7% vs. 6.6%) le ho khaotsa ho sebelisa lithethefatsi tse ithutoang ka lebaka la liketsahalo tse mpe (2.1% vs. 4.1%) li ile tsa hlokomeloa ho bakuli ba nang le tekanyo ea PAXLOVID ™ ha ba bapisoa le placebo, ka ho latellana.
Mabapi le PAXLOVID™ (PF-07321332; ritonavir) le Lenaneo la Ntlafatso la EPIC
PAXLOVID ™ ke lipatlisiso tsa SARS-CoV-2 protease inhibitor antiviral therapy, e etselitsoeng ka ho khetheha hore e fanoe ka molomo e le hore e ka fanoa ka letšoao la pele la ts'oaetso kapa qalong ea tlhokomeliso ea ho pepeseha, e ka thusang bakuli ho qoba ho kula ho matla ho ka lebisang. ho kena sepetlele le lefu.PF-07321332 e etselitsoe ho thibela ts'ebetso ea SARS-CoV-2-3CL protease, enzyme eo coronavirus e hlokang ho e etsa.Tšebelisano-'moho e nang le tekanyo e tlase ea ritonavir e thusa ho liehisa metabolism, kapa ho senyeha ha PF-07321332 e le hore e lule e le mafolofolo 'meleng nako e telele e le maemong a holimo ho thusa ho loants'a vaerase.
PF-07321332 e thibela ho ikatisa ha kokoana-hloko sethaleng se tsejoang e le proteolysis, e hlahang pele ho ikatisa ea vaerase ea RNA.Lithutong tsa pele, PF-07321332 ha ea ka ea bontša bopaki ba ho sebelisana ha DNA ea mutagenic.
Pfizer e qalile boithuto ba EPIC-HR ka Phupu 2021 ho latela liphetho tse ntle tsa liteko tsa bongaka tsa Mokhahlelo oa 1 mme o ntse a tsoela pele ho lekola antiviral ea lipatlisiso lithutong tse ling tsa EPIC.Ka Phato 2021, Pfizer e ile ea qala Phase 2/3 EPIC-SR (Avaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients), ho lekola katleho le polokeho ho bakuli ba nang le tlhahlobo e netefalitsoeng ea tšoaetso ea SARS-CoV-2 ba nang le tšoaetso. kotsing e tloaelehileng (ke hore, kotsi e tlase ea ho kena sepetlele kapa lefu).EPIC-SR e kenyelletsa sehlopha sa bakuli ba entoeng ba nang le ts'oaetso e matla ea matšoao a COVID-19 mme ba nang le mabaka a kotsi bakeng sa bokuli bo matla.Ka Loetse, Pfizer e ile ea qala Phase 2/3 EPIC-PEP (Avaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) ho lekola katleho le polokeho ho batho ba baholo ba pepeselitsoeng SARS-CoV-2 ke setho sa lelapa.
Ho fumana lintlha tse ling mabapi le liteko tsa bongaka tsa EPIC Phase 2/3 tsa PAXLOVID™, etela Clinictrials.gov.
Mabapi le Boitlamo ba Pfizer ho phihlello e lekanang
Pfizer e ikemiselitse ho sebeletsa ho fihlella phihlello e lekanang ho PAXLOVID™ bakeng sa batho bohle, e ikemiselitse ho fana ka kalafo e sireletsehileng le e sebetsang ea antiviral kapele kamoo ho ka khonehang le ka theko e tlase.Haeba mokhethoa oa rona a atlehile, nakong ea seoa sena, Pfizer e tla fana ka kalafo ea rona ea lipatlisiso ea antiviral ka mokhoa o hlophisitsoeng oa litheko o ipapisitseng le boemo ba lekeno la naha ka 'ngoe ho khothaletsa tekano ea phihlello lefatšeng ka bophara.Linaha tse nang le chelete e kenang e holimo le e holimo-limo li tla lefa ho feta linaha tse nang le chelete e tlaase.Khampani e kene litumellanong tsa ho reka esale pele le linaha tse ngata 'me e ntse e buisana le tse ling tse ngata.Pfizer e boetse e se e qalile 'me e tla tsoelapele ho tsetela ho fihlela ho $1 bilione ho ts'ehetsa tlhahiso le kabo ea kalafo ena ea lipatlisiso, ho kenyeletsoa le ho lekola likhetho tse ka bang teng tsa tlhahiso ea likonteraka ho thusa ho netefatsa phihlello ho linaha tse nang le meputso e tlase le e bohareng, ha ho ntse ho emetse tumello ea taolo.
Khamphani e sebeletsa ho netefatsa phihlello ea mokhethoa oa eona o mocha oa antiviral bakeng sa ba hlokang haholo lefats'eng ka bophara, ha ho ntse ho emetse liphetho tse atlehileng tsa liteko le tumello ea taolo.
Nako ea poso: Nov-19-2021