Pōʻalima, Nowemapa 05, 2021 - 06:45am
Ua ʻike ʻia ʻo PAXLOVID ™ (PF-07321332; ritonavir) e hōʻemi i ka pilikia o ka hale maʻi a i ʻole ka make ma ka 89% i hoʻohālikelike ʻia me kahi placebo i nā pākeke kiʻekiʻe kiʻekiʻe me COVID-19.
Ma ka heluna kanaka noiʻi holoʻokoʻa a hiki i ka lā 28, ʻaʻohe make i hōʻike ʻia i nā poʻe maʻi i loaʻa iā PAXLOVID™ ke hoʻohālikelike ʻia me 10 mau make i nā maʻi i loaʻa kahi placebo.
Hoʻolālā ʻo Pfizer e hoʻouna i ka ʻikepili ma ke ʻano he ʻāpana o kāna hoʻouna ʻana i ka US FDA for Emergency Use Authorization (EUA) i ka hiki wawe.
NEW YORK–(BUSINESS WIRE)– Ua hoʻolaha ʻo Pfizer Inc. (NYSE: PFE) i kēia lā i kāna puke noiʻi COVID-19 waha antiviral moho, ʻo PAXLOVID ™, i hōʻemi nui ʻia i ka hale maʻi a me ka make, e pili ana i kahi loiloi interim o ka Phase 2/3 EPIC- HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult people with COVID-19, who are at high risk of progressing to maʻi koʻikoʻi.Ua hōʻike ʻia ka loiloi interim i hoʻopaʻa ʻia he 89% ka hōʻemi ʻana i ka pilikia o ka haukapila pili i ka COVID-19 a i ʻole ka make mai kekahi kumu i hoʻohālikelike ʻia me ka placebo i nā maʻi i mālama ʻia i loko o ʻekolu mau lā o ka hoʻomaka ʻana o ka hōʻailona (hopena mua);ʻO 0.8% o nā maʻi i loaʻa iā PAXLOVID ™ i mālama ʻia i ka haukapila ma o ka lā 28 ma hope o ka randomization (3/389 halemai me ka make ʻole), hoʻohālikelike ʻia me 7.0% o nā maʻi i loaʻa i kahi placebo a ua hoʻokipa ʻia a make paha (27/385 i mālama ʻia me 7 mau make ma hope).Ua kiʻekiʻe ke koʻikoʻi helu helu o kēia mau hopena (p<0.0001).Ua ʻike ʻia nā hōʻemi like i ka hale maʻi e pili ana i ka COVID-19 a i ʻole ka make i nā maʻi i mālama ʻia i loko o ʻelima mau lā o ka hoʻomaka ʻana o ka hōʻailona;ʻO 1.0% o nā maʻi i loaʻa iā PAXLOVID ™ i mālama ʻia i ka haukapila ma o ka lā 28 ma hope o ka randomization (6/607 halemai, me ka make ʻole), hoʻohālikelike ʻia me 6.7% o nā maʻi i loaʻa kahi placebo (41/612 halemai me 10 mau make ma hope), me ka helu helu kiʻekiʻe. koʻikoʻi (p<0.0001).Ma ka heluna kanaka noiʻi holoʻokoʻa a hiki i ka lā 28, ʻaʻohe make i hōʻike ʻia i nā poʻe maʻi i loaʻa iā PAXLOVID ™ i hoʻohālikelike ʻia me 10 (1.6%) make i nā maʻi i loaʻa kahi placebo.
Ma ka ʻōlelo aʻoaʻo a ke Kōmike Monitoring Data kūʻokoʻa a me ke kūkākūkā ʻana me ka US Food and Drug Administration (FDA), e hoʻopau ʻo Pfizer i ke kākau inoa ʻana i loko o ke aʻo ʻana ma muli o ka mana nui i hōʻike ʻia i kēia mau hopena a me nā hoʻolālā e waiho i ka ʻikepili ma ke ʻano o kāna. ke hoʻomau nei ka hoʻouna ʻana i ka US FDA no ka ʻae ʻana i ka Emergency Use Authorization (EUA) i ka hiki.
"ʻO ka nūhou o kēia lā he mea hoʻololi pāʻani maoli i ka hoʻoikaika honua e pale i ka luku ʻana o kēia maʻi maʻi.Hōʻike kēia mau ʻikepili i kā mākou moho antiviral waha, inā ʻae ʻia a ʻae ʻia e nā luna hoʻoponopono, hiki ke hoʻopakele i nā ola o nā mea maʻi, hoʻemi i ka nui o nā maʻi COVID-19, a hoʻopau i ʻeiwa o nā hale hoʻomaha ʻumi, "wahi a Albert Bourla. Lunahoomalu a Luna Nui, Pfizer."Ma muli o ka hopena o ka honua holoʻokoʻa o COVID-19, ua hoʻomau mākou i ka nānā ʻana i ka laser i ka ʻepekema a hoʻokō i kā mākou kuleana e kōkua i nā ʻōnaehana olakino a me nā ʻoihana a puni ka honua aʻo ka hōʻoia ʻana i ke kaulike a me ka ākea ākea i nā poʻe ma nā wahi āpau."
Inā ʻae ʻia a ʻae ʻia paha, ʻo PAXLOVID ™, ka mea i hoʻokumu ʻia i loko o nā laboratories o Pfizer, ʻo ia ka antiviral waha mua o kāna ʻano, kahi mea hoʻopiʻi protease SARS-CoV-2-3CL.I ka pau ʻana o ke koena o ka papahana hoʻomohala lapaʻau EPIC a ma lalo o ka ʻae a i ʻole ka ʻae ʻia, hiki ke kuhikuhi ʻia ma ke ʻano he lāʻau lapaʻau ma ka home e kōkua i ka hōʻemi ʻana i ka nui o ka maʻi, nā halemai, a me nā make, a me ka hōʻemi ʻana i ka nui o ka maʻi. ma hope o ka hoʻolaha ʻana, ma waena o nā mākua.Ua hōʻike ʻo ia i ka hana antiviral in vitro ikaika e kūʻē i nā ʻano like ʻole o ka hopohopo, a me nā coronaviruses ʻē aʻe i ʻike ʻia, e hōʻike ana i kona hiki ke ʻano he therapeutic no nā ʻano maʻi coronavirus.
"Ke haʻaheo nei mākou a pau ma Pfizer i kā mākou mau ʻepekema, nāna i hoʻolālā a hoʻomohala i kēia mole, e hana ana me ka wikiwiki loa e kōkua i ka hōʻemi ʻana i ka hopena o kēia maʻi ʻino i nā maʻi a me ko lākou mau kaiāulu," wahi a Mikael Dolsten, MD, PhD., Luna Hoʻonaʻauao Nui a me Pelekikena, Noiʻi, Hoʻomohala a me ka Lapaʻau o Pfizer."Mahalo nui mākou i nā poʻe maʻi, nā mea noiʻi, a me nā pūnaewele a puni ka honua i komo i kēia hoʻokolohua lapaʻau, nā mea āpau me ka pahuhopu maʻamau o ka hoʻopuka ʻana i kahi lāʻau oral breakthrough e kōkua i ke kaua ʻana iā COVID-19."
Ua hoʻomaka ka haʻawina Phase 2/3 EPIC-HR i ke kākau inoa ʻana ma Iulai 2021. ʻO ka Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) a me EPIC-PEP (Evaluation of Protease Inhibition for COVID- 19 ma Post-Exposure Prophylaxis) nā haʻawina, i hoʻomaka ʻia ma ʻAukake a me Kepakemapa 2021, ʻaʻole i hoʻokomo ʻia i loko o kēia loiloi manawa a ke hoʻomau nei.
E pili ana i ka Phase 2/3 EPIC-HR Study Interim Analysis
ʻO ka loiloi mua o ka pūʻulu ʻikepili manawa i loiloi ʻia i ka ʻikepili mai 1219 mau mākua i kākau inoa ʻia e Kepakemapa 29, 2021. I ka manawa o ka hoʻoholo ʻana e hoʻōki i ka hoʻomaʻamaʻa ʻana i nā mea maʻi, ua kākau inoa ʻia ma 70% o nā maʻi 3,000 i hoʻolālā ʻia mai nā kahua hoʻokolohua lapaʻau ma ʻĀkau a ʻAmelika Hema, ʻEulopa, ʻApelika, a me ʻAsia, me 45% o nā maʻi ma ʻAmelika Hui Pū ʻIa.Ua loaʻa i ka poʻe i hoʻopaʻa inoa ʻia kahi maʻi i hōʻoia ʻia i ka maʻi SARS-CoV-2 i loko o ka manawa ʻelima mau lā me nā hōʻailona haʻahaʻa a maʻalahi a koi ʻia e loaʻa i hoʻokahi ʻano a i ʻole ka maʻi olakino e pili ana me ka piʻi nui o ka hoʻomohala ʻana i ka maʻi nui mai COVID. -19.Ua koho ʻia kēlā me kēia maʻi (1:1) e loaʻa iā PAXLOVID™ a i ʻole placebo ma ka waha i kēlā me kēia 12 hola no ʻelima mau lā.
E pili ana i ka Phase 2/3 EPIC-HR Study Safety Data
ʻO ka loiloi o kaʻikepili palekana i komo i kahi hui nui o nā maʻi 1881 ma EPIC-HR, nona kaʻikepili i loaʻa i ka manawa o ka nānāʻana.Hoʻohālikelike ʻia nā hanana ʻino i ka lāʻau lapaʻau ma waena o PAXLOVID™ (19%) a me kahi placebo (21%), ʻo ka hapa nui o ia mau mea he haʻahaʻa i ka ikaika.Ma waena o nā mea maʻi i loiloi ʻia no ka mālama ʻana i nā hanana ʻino, ʻoi aku ka liʻiliʻi o nā hanana koʻikoʻi koʻikoʻi (1.7% vs. 6.6%) a me ka hoʻopau ʻana i ke aʻo ʻana i ka lāʻau lapaʻau ma muli o nā hanana ʻino (2.1% vs. 4.1%) i ʻike ʻia i nā maʻi i hoʻopaʻa ʻia me PAXLOVID ™ i hoʻohālikelike ʻia me placebo, kēlā me kēia.
E pili ana iā PAXLOVID™ (PF-07321332; ritonavir) a me ka EPIC Development Program
ʻO PAXLOVID ™ kahi hoʻokolohua antiviral therapy antiviral protease inhibitor SARS-CoV-2, i hoʻolālā ʻia e lawelawe waha ʻia i hiki ke kuhikuhi ʻia i ka hōʻailona mua o ka maʻi a i ʻole ka ʻike mua ʻana i kahi hōʻike, hiki ke kōkua i nā poʻe maʻi e pale i ka maʻi koʻikoʻi hiki ke alakaʻi. i ka halemai a me ka make.Hoʻolālā ʻia ʻo PF-07321332 e ālai i ka hana o ka SARS-CoV-2-3CL protease, kahi enzyme e pono ai ka coronavirus e hana hou.ʻO ka hui pū ʻana me kahi haʻahaʻa haʻahaʻa o ritonavir e kōkua i ka lohi i ka metabolism, a i ʻole ka haki ʻana, o PF-07321332 i mea e hoʻomau ai i ke kino no nā manawa lōʻihi ma nā ʻano kiʻekiʻe e kōkua i ke kaua ʻana i ka maʻi.
Kāohi ʻo PF-07321332 i ka hoʻopiʻi hou ʻana i ka maʻi ma kahi ʻano i kapa ʻia ʻo proteolysis, e kū ana ma mua o ka hoʻopiʻi ʻana i ka viral RNA.Ma nā haʻawina preclinical, ʻaʻole i hōʻike ʻo PF-07321332 i nā hōʻike o ka pilina DNA mutagenic.
Ua hoʻomaka ʻo Pfizer i ka noiʻi EPIC-HR i Iulai 2021 ma hope o nā hopena hoʻokolohua lapaʻau Phase 1 maikaʻi a hoʻomau i ka loiloi i ka antiviral hoʻokolokolo ma nā haʻawina EPIC hou.I ʻAukake 2021, ua hoʻomaka ʻo Pfizer i ka Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients), e loiloi i ka pono a me ka palekana i nā poʻe maʻi me kahi hōʻoia i hōʻoia ʻia o ka maʻi SARS-CoV-2. i ka pilikia maʻamau (ʻo ia hoʻi, ka liʻiliʻi o ka hoʻokipa a i ʻole ka make).Loaʻa i ka EPIC-SR kahi pūʻulu o nā mea maʻi i hoʻopaʻa ʻia i loaʻa i ka maʻi maʻi maʻi maʻi COVID-19 a loaʻa nā kumu pilikia no ka maʻi koʻikoʻi.I Kepakemapa, ua hoʻomaka ʻo Pfizer i ka Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) e loiloi i ka pono a me ka palekana i nā pākeke i hōʻike ʻia iā SARS-CoV-2 e kahi lālā o ka hale.
No ka 'ike hou aku e pili ana i ka EPIC Phase 2/3 ho'āʻo hoʻokolohua no PAXLOVID™, e kipa i clinicaltrials.gov.
E pili ana i ko Pfizer hoʻohiki i ke komo kaulike
Ua paʻa ʻo Pfizer i ka hana ʻana i ke komo kaulike i PAXLOVID ™ no nā poʻe āpau, e manaʻo ana e hoʻopuka i nā lāʻau antiviral palekana a me ka maikaʻi i ka wā hiki loa a ma ke kumukūʻai kūpono.Inā kūleʻa kā mākou moho, i ka wā maʻi maʻi, e hāʻawi ʻo Pfizer i kā mākou hoʻokolokolo antiviral antiviral therapy ma o ke ʻano kumukūʻai tiered e pili ana i ka pae o ka loaʻa kālā o kēlā me kēia ʻāina e hāpai i ke kaulike o ke komo ʻana ma ka honua holoʻokoʻa.ʻOi aku ka uku o nā ʻāina kiʻekiʻe a me waena waena ma mua o nā ʻāina haʻahaʻa.Ua komo ka hui i nā ʻaelike kūʻai mua me nā ʻāina he nui a ke kūkākūkā nei me nā mea ʻē aʻe.Ua hoʻomaka pū ʻo Pfizer a e hoʻomau i ka hoʻopukapuka kālā a hiki i kahi $ 1 biliona e kākoʻo i ka hana ʻana a me ka hāʻawi ʻana i kēia hoʻokolokolo hoʻokolokolo, me ka ʻimi ʻana i nā koho hana hana ʻaelike e kōkua i ka hōʻoia ʻana i ke komo ʻana ma waena o nā ʻāina haʻahaʻa a me waena, e kali ana i ka mana hoʻoponopono.
Ke hana nei ka ʻoihana e hōʻoia i ka loaʻa ʻana o kāna moho antiviral hou no ka poʻe i nele a puni ka honua, ke kali nei i nā hopena hoʻokolokolo kūleʻa a me ka ʻae ʻia ʻana.
Ka manawa hoʻouna: Nov-19-2021