Chishanu, Mbudzi 05, 2021 - 06:45 am
PAXLOVID™ (PF-07321332; ritonavir) yakawanikwa ichidzikisa njodzi yekuiswa muchipatara kana kufa ne89% zvichienzaniswa ne placebo mune vasiri muchipatara vakuru vane njodzi huru yeCOVID-19.
Muhuwandu hwekudzidza kuburikidza neZuva 28, hapana kufa kwakataurwa kune varwere vakagamuchira PAXLOVID ™ kana zvichienzaniswa ne10 kufa kwevarwere vakagamuchira placebo.
Pfizer inoronga kuendesa iyo data sechikamu chekuenderera kwayo kuendesa kuUS FDA yeEmergency Use Authorization (EUA) nekukurumidza sezvinobvira.
NEW YORK- (BUSINESS WIRE) - Pfizer Inc. (NYSE: PFE) nhasi yazivisa chinyorwa chayo chekuongorora COVID-19 chemuromo antiviral mumiriri, PAXLOVID™, yakaderedza zvakanyanya kuchipatara uye kufa, zvichibva pakuongorora kwechinguvana kweChikamu 2/3 EPIC- HR (Kuongorora kweProtease Inhibition yeCCIDID-19 muVarwere Vepamusoro-soro) yakasarudzika, yakapetwa kaviri-mapofu kudzidza kwevarwere vakura vasiri muchipatara vane COVID-19, vari panjodzi huru yekuenderera mberi nehurwere hwakanyanya.Ongororo yenguva pfupi yakarongwa yakaratidza kudzikiswa kwe89% munjodzi yeCOVID-19-inoenderana-muchipatara kana kufa kubva kune chero chikonzero zvichienzaniswa ne placebo muvarwere vanorapwa mukati memazuva matatu ekutanga kwechiratidzo (yekutanga magumo);0.8% yevarwere vakagamuchira PAXLOVID ™ vakaiswa muchipatara kuburikidza neZuva 28 zvichitevera randomization (3/389 muchipatara pasina rufu), zvichienzaniswa ne7.0% yevarwere vakagamuchira placebo uye vakaiswa muchipatara kana kufa (27/385 muchipatara ne7.Kukosha kwehuwandu hwemigumisiro iyi kwaive kwakakwira (p <0.0001).Kudzikiswa kwakafanana muchipatara cheCCIDID-19 kana kufa kwakaonekwa muvarwere vakarapwa mukati memazuva mashanu ekutanga kwechiratidzo;1.0% yevarwere vakagamuchira PAXLOVID ™ vakaiswa muchipatara kuburikidza neZuva 28 zvichitevera randomisation (6/607 muchipatara, pasina rufu), zvichienzaniswa ne6.7% yevarwere vakagamuchira placebo (41/612 muchipatara ne10 kufa kwakazotevera), ine huwandu hwakawanda. kukosha (p <0.0001).Muhuwandu hwekudzidza kuburikidza neZuva 28, hapana kufa kwakataurwa kune varwere vakagamuchira PAXLOVID ™ kana zvichienzaniswa negumi (1.6%) vakafa muvarwere vakagamuchira placebo.
Pakurudziro yekomiti yakazvimirira yeData Monitoring Committee uye nekubvunzana neUS Food and Drug Administration (FDA), Pfizer achamira kunyoresa muchidzidzo ichi nekuda kwekuita kwakasimba kunoratidzwa mune izvi zvabuda uye kuronga kuendesa data sechikamu chayo. kuenderera mberi kwekutumira kuUS FDA yeEmergency Use Authorization (EUA) nekukurumidza sezvinobvira.
“Nhau dzanhasi ishanduko chaiyo mukuedza kwepasi rose kumisa kuparara kwedenda iri.Idzi data dzinoratidza kuti mumiriri wedu wepamuromo antiviral, kana akabvumidzwa kana kubvumidzwa nevakuru vane masimba, ane mukana wekuponesa hupenyu hwevarwere, kuderedza hukasha hwehutachiona hweCCIDID-19, uye kubvisa vanosvika vapfumbamwe kubva mugumi muchipatara, "akadaro Albert Bourla, Sachigaro uye Chief Executive Officer, Pfizer."Nekuda kwekuenderera mberi kwekuita kweCCIDID-19 pasi rose, isu takaramba takatarisa pasainzi uye tichizadzisa basa redu rekubatsira masystem ehutano nemasangano pasirese tichiona mukana wakaenzana uye wakafara kuvanhu kwese kwese."
Kana yakatenderwa kana kubvumidzwa, PAXLOVID™, iyo yakatanga mumarabhoritari ePfizer, ingave yekutanga yemuromo antiviral yerudzi rwayo, yakanyatsogadzirwa SARS-CoV-2-3CL protease inhibitor.Pakupera kwekubudirira kwezvakasara zveEPIC chirongwa chekuvandudza kiriniki uye zvichienderana nemvumo kana mvumo, inogona kurongedzerwa zvakanyanya sekurapa kumba kubatsira kuderedza kuoma kwehurwere, kuchipatara, uye kufa, pamwe nekuderedza mukana wekutapukirwa. kutevera kuratidzwa, pakati pevakuru.Yakaratidza simba reantiviral in vitro chiitiko chinopesana nekutenderera kwakasiyana kwekunetseka, pamwe nemamwe anozivikanwa coronaviruses, zvichiratidza kugona kwayo semushonga wemhando dzakawanda dzehutachiona hwekoronavirus.
"Isu tese kuPfizer tinodada zvakanyanya nemasayendisiti edu, akagadzira uye akagadzira morekuru uyu, achishanda nekukasira kubatsira kuderedza kukanganiswa kwechirwere ichi kuvarwere nenharaunda dzavanogara," akadaro Mikael Dolsten, MD, PhD., Chief Scientific Officer uye Mutungamiri, Worldwide Research, Development uye Medical yePfizer."Tinotenda kune vese varwere, vaongorori, uye masosi pasirese vakapinda muyedzo yekiriniki iyi, zvese nechinangwa chekuunza budiriro yekurapa nemuromo kubatsira kurwisa COVID-19."
Chidzidzo chePhase 2/3 EPIC-HR chakatanga kunyoresa muna Chikunguru 2021. The Phase 2/3 EPIC-SR (Kuongorora kweProtease Inhibition yeCOVID-19 muStandard-Risk Patients) uye EPIC-PEP (Kuongorora kweProtease Inhibition yeCOVID- 19 muPost-Exposure Prophylaxis) zvidzidzo, zvakatanga muna Nyamavhuvhu naGunyana 2021 zvakateerana, hazvina kuverengerwa muongororo iyi yenguva uye zviri kuenderera mberi.
Nezve Chikamu 2/3 EPIC-HR Chidzidzo Chenguva Yekuongorora
Kuongorora kwekutanga kwe data yenguva pfupi yakaongororwa data kubva kune vanhu vakuru 1219 vakanyoreswa neSeptember 29, 2021. Panguva yesarudzo yekurega kutora varwere, kunyoresa kwaiva pa70% yevarwere 3,000 vakarongwa kubva munzvimbo dzemakiriniki dzemakiriniki mhiri kweNorth uye. South America, Europe, Africa, neAsia, ine 45% yevarwere vari muUnited States.Vanhu vakanyoresa vaive nerabhoritari-yakasimbiswa kuongororwa kwehutachiona hweSARS-CoV-2 mukati memazuva mashanu vaine zviratidzo zvakapfava kusvika pakati nepakati uye vaifanirwa kuve nehunhu humwechete kana mamiriro ekurapa ane chekuita nenjodzi yakawedzera yekurwara zvakanyanya kubva kuCOVID. -19.Murwere wega wega aive asina kurongeka (1: 1) kugamuchira PAXLOVID ™ kana placebo nemuromo maawa gumi nemaviri kwemazuva mashanu.
Nezve Chikamu 2/3 EPIC-HR Chidzidzo Chekuchengetedza Dhata
Kuongororwa kwekuchengetedzwa kwekuchengetedzwa kwaisanganisira boka guru revarwere ve1881 muEPIC-HR, avo vane ruzivo rwakanga rwuripo panguva yekuongorora.Kurapa-zvinoitika zvakashata zvakange zvakaenzana pakati pePAXLOVID ™ (19%) uye placebo (21%), mazhinji acho aive munyoro mukusimba.Pakati pevarwere vanoongororwa kurapwa-kune zviitiko zvakashata zvakashata, zvishomanana zvakakomba zviitiko (1.7% vs. 6.6%) uye kurega kudzidza zvinodhaka nekuda kwezviitiko zvakashata (2.1% vs. 4.1%) zvakaonekwa kune varwere vakadhayiwa nePAXLOVID ™ zvichienzaniswa ne placebo, zvichiteerana.
Nezve PAXLOVID™ (PF-07321332; ritonavir) uye EPIC Development Program.
PAXLOVID ™ ndeyekuferefeta SARS-CoV-2 protease inhibitor antiviral therapy, yakanyatsogadzirirwa kupihwa nemuromo kuitira kuti igone kurongerwa pachiratidzo chekutanga chehutachiona kana pekutanga kuziva nezvekufumurwa, zvinogona kubatsira varwere kudzivirira kurwara kwakanyanya kunogona kutungamira. kuchipatara uye kufa.PF-07321332 yakagadzirirwa kuvharidzira chiitiko cheSARS-CoV-2-3CL protease, enzyme iyo coronavirus inoda kutevedzera.Kubata pamwe chete nedosi yakaderera yeritonavir kunobatsira kunonotsa metabolism, kana kuputsika, kwePF-07321332 kuitira kuti irambe ichishanda mumuviri kwenguva yakareba panguva yakakwira kubatsira kurwisa hutachiona.
PF-07321332 inodzivisa kudzokororwa kwehutachiwana padanho rinozivikanwa seproteolysis, rinoitika hutachiona hweRNA isati yadzokororwa.Muzvidzidzo zvepreclinical, PF-07321332 haina kuratidza humbowo hwemutagenic DNA kusangana.
Pfizer akatanga chidzidzo cheEPIC-HR muna Chikunguru 2021 zvichitevera mhinduro yakanaka yeChikamu 1 yekiriniki uye anoenderera mberi nekuongorora antiviral yekuferefeta mune zvimwe zvidzidzo zveEPIC.Muna Nyamavhuvhu 2021, Pfizer akatanga Phase 2/3 EPIC-SR (Kuongorora kweProtease Inhibition yeCCIDID-19 muStandard-Risk Patients), kuongorora kushanda uye kuchengetedzeka muvarwere vane chirwere chakasimbiswa cheSARS-CoV-2 hutachiona. panjodzi yakajairika (kureva, njodzi yakaderera yekurapwa muchipatara kana kufa).EPIC-SR inosanganisira boka revarwere vakabaiwa vane hutachiona hwehutachiona hweCCIDID-19 uye vane njodzi dzehurwere hwakanyanya.MunaGunyana, Pfizer akatanga Phase 2/3 EPIC-PEP (Kuongorora kweProtease Inhibition yeCOVID-19 muPost-Exposure Prophylaxis) kuongorora kushanda uye kuchengetedzeka muvakuru vakafumurwa kuSARS-CoV-2 nenhengo yemhuri.
Kuti uwane rumwe ruzivo nezve EPIC Phase 2/3 kiriniki miedzo yePAXLOVID™, shanyira Clinictrials.gov.
Nezve Pfizer's Kuzvipira kune Equitable Access
Pfizer yakazvipira kushandira kuwana kwakaenzana kuPAXLOVID™ kune vanhu vese, iine chinangwa chekuunza yakachengeteka uye inoshanda antiviral therapeutics nekukurumidza uye nemutengo unokwanisika.Kana mumiriri wedu akabudirira, panguva yedenda, Pfizer ichapa yedu yekuferefeta yemuromo antiviral kurapa kuburikidza neyakaomeswa mitengo nzira yakavakirwa padanho remari yenyika yega yega kusimudzira kuenzana kwekuwana pasirese.Nyika dzinotambira mari yepamusoro nepamusoro-soro dzichabhadhara kudarika nyika dzine mari shoma.Kambani yakapinda muzvibvumirano zvekutenga kare nenyika dzakawanda uye iri munhaurirano nevamwe vakati wandei.Pfizer yatangawo uye icharamba ichidyara mari inosvika bhiriyoni imwe yekutsigira kugadzirwa uye kugovera kurapwa uku, kusanganisira kuongorora zvingangoitika zvekugadzira kondirakiti nzira dzekubatsira kuwana nyika dzine mari yakaderera nepakati, zvichimirira kupihwa mvumo.
Kambani iyi iri kushanda kuti ive nechokwadi chekuwana mukana weanovel antiviral mumiriri kune avo vanonyanya kuda pasirese, ichimirira mhedzisiro yemuyedzo uye kubvumidzwa kwemutemo.
Nguva yekutumira: Nov-19-2021