Juma'a, Nuwamba 05, 2021 - 06:45 na safe
An gano PAXLOVID ™ (PF-07321332; ritonavir) don rage haɗarin asibiti ko mutuwa da kashi 89% idan aka kwatanta da placebo a cikin manya marasa haɗarin asibiti tare da COVID-19
A cikin yawan binciken gabaɗaya ta hanyar ranar 28, ba a ba da rahoton mutuwar a cikin marasa lafiya waɗanda suka karɓi PAXLOVID ™ idan aka kwatanta da mutuwar 10 a cikin marasa lafiya waɗanda suka karɓi placebo.
Pfizer yana shirin ƙaddamar da bayanan a matsayin wani ɓangare na ci gaba da ƙaddamar da ƙaddamarwa ga FDA ta Amurka don Izinin Amfani da Gaggawa (EUA) da wuri-wuri.
NEW YORK – (WIRE KASUWANCI) – Pfizer Inc. (NYSE: PFE) a yau ta sanar da sabon littafin bincikenta na COVID-19 ɗan takarar antiviral na baka, PAXLOVID ™, ya rage yawan asibiti da mutuwa, dangane da nazarin wucin gadi na Mataki na 2/3 EPIC- HR (Kimanin Hana Protease don COVID-19 a cikin Marasa lafiya Masu Haɗari) bazuwar, binciken makafi biyu na manya marasa lafiya marasa asibiti tare da COVID-19, waɗanda ke cikin haɗarin ci gaba zuwa rashin lafiya mai tsanani.Binciken wucin gadi da aka tsara ya nuna raguwar kashi 89 cikin 100 na haɗarin asibiti da ke da alaƙa da COVID-19 ko mutuwa daga kowane dalili idan aka kwatanta da placebo a cikin marasa lafiya da aka yi wa magani a cikin kwanaki uku na farkon bayyanar cututtuka (maganin farko);0.8% na marasa lafiya da suka karɓi PAXLOVID ™ an kwantar da su ta hanyar ranar 28 bayan bazuwar (3/389 asibiti ba tare da mutuwa ba), idan aka kwatanta da 7.0% na marasa lafiya waɗanda suka karɓi placebo kuma an kwantar da su ko kuma sun mutu (27/385 asibiti tare da mutuwar 7 masu zuwa).Mahimman ƙididdiga na waɗannan sakamakon ya kasance babba (p<0.0001).An sami ragi makamancin haka a asibiti ko mutuwa masu alaƙa da COVID-19 a cikin majinyata da aka yi musu magani a cikin kwanaki biyar na farkon alamun;1.0% na marasa lafiya da suka karɓi PAXLOVID ™ an kwantar da su ta hanyar ranar 28 bayan bazuwar (6/607 asibiti, ba tare da mutuwa ba), idan aka kwatanta da 6.7% na marasa lafiya waɗanda suka karɓi placebo (41/612 asibiti tare da mutuwar 10 masu zuwa), tare da babban kididdiga. mahimmanci (p <0.0001).A cikin yawan binciken gabaɗaya ta hanyar Rana 28, ba a sami rahoton mutuwar a cikin marasa lafiya waɗanda suka karɓi PAXLOVID ™ idan aka kwatanta da mutuwar 10 (1.6%) a cikin marasa lafiya waɗanda suka karɓi placebo.
Dangane da shawarar wani kwamiti mai zaman kansa na Kula da Bayanai da kuma tuntuɓar Hukumar Kula da Abinci da Magunguna ta Amurka (FDA), Pfizer za ta daina ƙara yin rajista a cikin binciken saboda gagarumin tasiri da aka nuna a cikin waɗannan sakamakon da kuma shirin ƙaddamar da bayanan a matsayin wani ɓangare na sa. mirgina mai gudana ga FDA ta Amurka don Izinin Amfani da Gaggawa (EUA) da wuri-wuri.
"Labarin yau shine ainihin mai canza wasa a ƙoƙarin duniya na dakatar da barnar wannan annoba.Waɗannan bayanan sun ba da shawarar cewa ɗan takarar mu na rigakafin cutar ta baka, idan an amince da shi ko kuma izini daga hukumomin da suka dace, yana da yuwuwar ceton rayukan marasa lafiya, da rage tsananin cututtukan COVID-19, da kuma kawar da kusan tara cikin goma na asibitoci, ”in ji Albert Bourla. Shugaba da Babban Jami'in Gudanarwa, Pfizer."Idan aka yi la'akari da ci gaba da tasirin COVID-19 a duniya, mun ci gaba da mai da hankali kan kimiyyar kimiyya tare da cika alhakinmu na taimakawa tsarin kiwon lafiya da cibiyoyi a duniya tare da tabbatar da daidaito da kuma isa ga mutane a ko'ina."
Idan an yarda ko ba da izini, PAXLOVID ™, wanda ya samo asali daga dakunan gwaje-gwaje na Pfizer, zai zama farkon nau'in rigakafin cutar ta baki, musamman mai hana cutar SARS-CoV-2-3CL.Bayan nasarar kammala sauran shirye-shiryen ci gaban asibiti na EPIC kuma bisa yarda ko izini, ana iya tsara shi sosai azaman magani na gida don taimakawa rage tsananin rashin lafiya, asibiti, da mace-mace, tare da rage yiwuwar kamuwa da cuta. bin fallasa, a tsakanin manya.Ya nuna aikin antiviral a cikin vitro mai ƙarfi game da bambance-bambancen damuwa, da sauran sanannun coronaviruses, yana ba da shawarar yuwuwar sa azaman magani ga nau'ikan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan cututtukan ƙwayoyin cuta.
"Dukkanmu a Pfizer muna matukar alfahari da masana kimiyyarmu, waɗanda suka tsara kuma suka haɓaka wannan kwayar halitta, suna aiki tare da matuƙar gaggawa don taimakawa rage tasirin wannan mummunar cuta ga marasa lafiya da al'ummominsu," in ji Mikael Dolsten, MD, PhD., Babban Jami'in Kimiyya da Shugaba, Bincike na Duniya, Ci gaba da Likita na Pfizer."Muna godiya ga dukkan majiyyata, masu bincike, da shafuka a duk duniya da suka shiga wannan gwajin na asibiti, duk tare da manufar gama gari na samar da ci gaba na maganin baka don taimakawa wajen yakar COVID-19."
Nazarin EPIC-HR na Mataki na 2/3 ya fara yin rajista a cikin Yuli 2021. Mataki na 2/3 EPIC-SR (Kimanin hanawar Protease don COVID-19 a cikin Ma'aikatan Haɗari) da EPIC-PEP (Kimanin Haɗin Protease don COVID- 19 a Post-Exposure Prophylaxis), wanda ya fara a watan Agusta da Satumba 2021 bi da bi, ba a haɗa su cikin wannan binciken na wucin gadi ba kuma yana gudana.
Game da Nazari na wucin gadi na Mataki na 2/3 EPIC-HR
Binciken farko na bayanan wucin gadi ya kimanta bayanai daga manya 1219 da aka yi rajista har zuwa Satumba 29, 2021. A lokacin yanke shawarar dakatar da daukar marasa lafiya, yin rajista ya kasance kashi 70% na marasa lafiya 3,000 da aka tsara daga wuraren gwaji na asibiti a fadin Arewa kuma Kudancin Amurka, Turai, Afirka, da Asiya, tare da 45% na marasa lafiya da ke cikin Amurka.Mutanen da suka yi rajista suna da gwajin gwajin gwajin da aka tabbatar da cutar ta SARS-CoV-2 a cikin kwanaki biyar tare da alamu masu sauƙi zuwa matsakaici kuma ana buƙatar samun aƙalla sifa ɗaya ko yanayin rashin lafiya da ke da alaƙa da haɓakar haɗarin kamuwa da cuta mai tsanani daga COVID. -19.An keɓe kowane majiyyaci (1:1) don karɓar PAXLOVID™ ko placebo baki ɗaya kowane awa 12 na kwana biyar.
Game da Bayanan Tsaro na Nazarin EPIC-HR na Mataki na 2/3
Binciken bayanan aminci ya haɗa da babban rukunin marasa lafiya na 1881 a cikin EPIC-HR, waɗanda bayanansu ke samuwa a lokacin bincike.Abubuwan da suka faru na gaggawa na jiyya sun yi kama da juna tsakanin PAXLOVID™ (19%) da placebo (21%), yawancinsu suna da sauƙi a cikin ƙarfi.Daga cikin marasa lafiya da ake kimantawa don abubuwan da suka faru na gaggawa na jiyya, ƙananan abubuwan da ba su da kyau (1.7% vs. 6.6%) da kuma dakatar da maganin miyagun ƙwayoyi saboda abubuwan da ba su da kyau (2.1% vs. 4.1%) an lura da su a cikin marasa lafiya da aka yi amfani da su tare da PAXLOVID ™ idan aka kwatanta da su. placebo, bi da bi.
Game da PAXLOVID™ (PF-07321332; ritonavir) da Shirin Ci gaban EPIC
PAXLOVID ™ bincike ne na SARS-CoV-2 protease inhibitor antiviral far, musamman tsara don gudanar da baki ta yadda za a iya rubuta shi a farkon alamar kamuwa da cuta ko kuma a farkon bayyanar da bayyanar, yiwuwar taimaka wa marasa lafiya su guje wa rashin lafiya mai tsanani wanda zai iya haifar da shi. zuwa asibiti da mutuwa.PF-07321332 an tsara shi don toshe ayyukan SARS-CoV-2-3CL protease, wani enzyme wanda coronavirus ke buƙatar maimaitawa.Gudanar da haɗin gwiwa tare da ƙananan kashi na ritonavir yana taimakawa rage ƙwayar cuta, ko rushewa, na PF-07321332 domin ta ci gaba da aiki a cikin jiki na tsawon lokaci a babban taro don taimakawa wajen yaki da cutar.
PF-07321332 yana hana kwafin kwayar cutar hoto a wani mataki da ake kira proteolysis, wanda ke faruwa kafin kwafin RNA na hoto.A cikin bincike na yau da kullun, PF-07321332 bai nuna shaidar mutagenic hulɗar DNA ba.
Pfizer ya ƙaddamar da binciken EPIC-HR a cikin Yuli 2021 yana bin ingantaccen sakamako na gwaji na asibiti na Mataki na 1 kuma ya ci gaba da kimanta gwajin rigakafin cutar a cikin ƙarin binciken EPIC.A cikin watan Agusta 2021, Pfizer ya ƙaddamar da Mataki na 2/3 EPIC-SR (Kimanin Inhibition Protease don COVID-19 a cikin Matsalolin Haɗari), don kimanta inganci da aminci a cikin marasa lafiya da aka tabbatar da kamuwa da cuta ta SARS-CoV-2 waɗanda ke da alaƙa. a daidaitaccen haɗari (watau ƙananan haɗarin asibiti ko mutuwa).EPIC-SR ya haɗa da ƙungiyar majinyata da aka yi wa alurar riga kafi waɗanda ke da alamun ci gaba mai saurin kamuwa da kamuwa da cuta ta COVID-19 kuma waɗanda ke da abubuwan haɗari na rashin lafiya mai tsanani.A watan Satumba, Pfizer ya ƙaddamar da Mataki na 2/3 EPIC-PEP (Kimanin Hana Protease don COVID-19 a cikin Prophylaxis Bayan Bayyana) don kimanta inganci da aminci a cikin manya da wani memba na gida ya fallasa ga SARS-CoV-2.
Don ƙarin bayani kan gwajin asibiti na EPIC Phase 2/3 don PAXLOVID™, ziyarci clinicaltrials.gov.
Game da Alƙawarin Pfizer don Samun Dama
Pfizer ya himmatu wajen yin aiki don samun daidaiton samun dama ga PAXLOVID™ ga duk mutane, da nufin isar da lafiya da ingantaccen maganin rigakafin cutar da wuri-wuri kuma a farashi mai araha.Idan ɗan takararmu ya yi nasara, yayin bala'in, Pfizer zai ba da bincikenmu na maganin rigakafin ƙwayar cuta ta hanyar ƙimar farashi dangane da matakin samun kudin shiga na kowace ƙasa don haɓaka daidaiton samun dama a duk faɗin duniya.Kasashe masu girma da masu matsakaicin kudin shiga za su biya fiye da kasashe masu karamin karfi.Kamfanin ya shiga yarjejeniyar sayan gaba da kasashe da yawa kuma yana cikin tattaunawa da wasu da dama.Har ila yau, Pfizer ya fara kuma zai ci gaba da saka hannun jari har kusan dala biliyan 1 don tallafawa masana'antu da rarraba wannan magani na bincike, gami da bincika yuwuwar zaɓuɓɓukan masana'antar kwangila don taimakawa wajen tabbatar da isa ga ƙasashe masu ƙanƙanta da matsakaita, masu jiran izini na tsari.
Kamfanin yana aiki don tabbatar da samun dama ga sabon ɗan takarar sa na rigakafin ƙwayar cuta ga waɗanda ke da buƙatu a duk duniya, yana jiran sakamakon gwaji na nasara da amincewar tsari.
Lokacin aikawa: Nuwamba-19-2021