Fraịde, Nọvemba 05, 2021 - 06:45 nke ụtụtụ
Achọpụtara PAXLOVID ™ (PF-07321332; ritonavir) iji belata ihe ize ndụ nke ụlọ ọgwụ ma ọ bụ ọnwụ site na 89% ma e jiri ya tụnyere placebo na ndị okenye na-abụghị ụlọ ọgwụ nwere COVID-19.
N'ime ọnụ ọgụgụ ọmụmụ ihe n'ozuzu ya site na ụbọchị 28, ọnweghị ọnwụ nwụrụ na ndị ọrịa natara PAXLOVID ™ ma e jiri ya tụnyere ọnwụ 10 na ndị ọrịa natara placebo.
Pfizer na-ezube ịnye data ahụ dị ka akụkụ nke nrubeisi ya na-aga n'ihu na ntinye aka na US FDA maka ikike iji ihe mberede (EUA) ozugbo enwere ike.
NEW YORK – (WIRE Azụmahịa) – Pfizer Inc. (NYSE: PFE) taa kwuputara akwụkwọ nyocha ya COVID-19 onye ndoro-ndoro mgbochi mgbochi ọnụ, PAXLOVID ™, belatara ụlọ ọgwụ na ọnwụ nke ukwuu, dabere na nyocha nwa oge nke usoro 2/3 EPIC- HR (Nnyocha nke Protease Inhibition maka COVID-19 na ndị ọrịa nwere nnukwu ihe ize ndụ) na-enweghị usoro, nyocha nke abụọ nke ndị okenye na-abụghị ụlọ ọgwụ nwere COVID-19, ndị nọ n'ihe ize ndụ nke ịga n'ihu na ọrịa siri ike.Nyocha nwa oge akwadoro gosipụtara mbelata 89% n'ihe ize ndụ nke ụlọ ọgwụ metụtara COVID-19 ma ọ bụ ọnwụ sitere na ihe ọ bụla ma e jiri ya tụnyere placebo na ndị ọrịa na-agwọ n'ime ụbọchị atọ nke mgbaàmà mmalite (isi njedebe);0.8% nke ndị ọrịa natara PAXLOVID ™ nọ n'ụlọ ọgwụ site na ụbọchị 28 na-esote randomization (3/389 n'ụlọ ọgwụ na-enweghị ọnwụ), ma e jiri ya tụnyere 7.0% nke ndị ọrịa natara placebo ma nọrọ n'ụlọ ọgwụ ma ọ bụ nwụọ (27/385 n'ụlọ ọgwụ na ọnwụ 7 na-esote).Ihe ndekọ ndekọ aha nke nsonaazụ ndị a dị elu (p<0.0001).Mbelata yiri nke ahụ na ụlọ ọgwụ ma ọ bụ ọnwụ metụtara COVID-19 na ndị ọrịa gwọchara n'ime ụbọchị ise nke mgbaàmà mmalite;1.0% nke ndị ọrịa natara PAXLOVID ™ nọ n'ụlọ ọgwụ site na ụbọchị 28 na-esote randomization (6/607 n'ụlọ ọgwụ, na-enweghị ọnwụ), ma e jiri ya tụnyere 6.7% nke ndị ọrịa natara placebo (41/612 n'ụlọ ọgwụ na ọnwụ 10 sochirinụ), yana ọnụ ọgụgụ dị elu. mkpa (p <0.0001).N'ime ọnụ ọgụgụ ọmụmụ ihe n'ozuzu site na ụbọchị 28, ọnweghị ọnwụ nwụrụ na ndị ọrịa natara PAXLOVID ™ ma e jiri ya tụnyere 10 (1.6%) ọnwụ na ndị ọrịa natara placebo.
Na ntụnye nke kọmitii na-ahụ maka data nọọrọ onwe ya yana na nyocha ya na US Food and Drug Administration (FDA), Pfizer ga-akwụsị ịdebanye aha ọzọ na ọmụmụ ahụ n'ihi oke arụmọrụ gosipụtara na nsonaazụ ndị a yana atụmatụ ịnyefe data dị ka akụkụ nke ya. Nrubeisi na-aga n'ihu nye US FDA maka ikike iji ihe mberede (EUA) ozugbo enwere ike.
"Akụkọ nke taa bụ ezigbo mgbanwe egwuregwu na mbọ zuru ụwa ọnụ iji kwụsị mbibi nke ọrịa a.Ihe omuma a na-egosi na onye ndoro-ndoro ochichi nke onu ogugu anyi, ma oburu na ndi isi ochichi kwadoro ma obu nye ya ikike, nwere ikike izoputa ndu ndi oria, belata oke oria COVID-19, ma wepu ihe ruru itoolu n'ime ulo ogwu iri, "Albert Bourla kwuru. Onye isi oche na onye isi nchịkwa, Pfizer."Nyere mmetụta na-aga n'ihu n'ụwa niile nke COVID-19, anyị ka lekwasịrị anya na sayensị na sayensị ma na-arụ ọrụ anyị iji nyere usoro nlekọta ahụike na ụlọ ọrụ gburugburu ụwa aka ka anyị na-ahụ n'ụzọ ziri ezi na ohere zuru ezu na ndị mmadụ n'ebe niile."
Ọ bụrụ na akwadoro ma ọ bụ nye ya ikike, PAXLOVID ™, nke sitere na ụlọ nyocha Pfizer, ga-abụ ọgwụ mgbochi mbụ nke ụdị ya, nke emebere SARS-CoV-2-3CL protease inhibitor.Mgbe emechara nke ọma nke fọdụrụ na mmemme mmepe ụlọ ọgwụ EPIC ma dabere na nkwado ma ọ bụ ikike, enwere ike ịhazi ya nke ọma dịka ọgwụgwọ n'ụlọ iji nyere aka belata ogo ọrịa, ụlọ ọgwụ, na ọnwụ, yana belata ohere nke ibute ọrịa. na-eso ikpughe, n'etiti ndị okenye.Ọ egosipụtala ọrụ antiviral siri ike na vitro megide ụdị nchegbu na-ekesa, yana coronaviruse ndị ọzọ a ma ama, na-atụ aro ike ya dị ka ọgwụgwọ maka ọtụtụ ụdị ọrịa coronavirus.
"Anyị niile na Pfizer nwere oke mpako maka ndị ọkà mmụta sayensị anyị, bụ ndị chepụtara ma mepụta molecule a, na-arụ ọrụ na ngwa ngwa iji nyere aka belata mmetụta nke ọrịa a na-ebibi ihe na ndị ọrịa na obodo ha," ka Mikael Dolsten, MD, PhD kwuru., Onye isi nchịkwa sayensị na Onye isi ala, nyocha zuru ụwa ọnụ, mmepe na ahụike nke Pfizer."Anyị nwere ekele maka ndị ọrịa niile, ndị nyocha na saịtị gburugburu ụwa bụ ndị sonyere na nnwale ụlọ ọgwụ a, ha niile nwere ebumnuche nke iwepụta usoro ọgwụgwọ ọnụ iji nyere aka ịlụso COVID-19 ọgụ."
Usoro ọmụmụ 2/3 EPIC-HR malitere ndebanye aha na Julaị 2021. Usoro 2/3 EPIC-SR (Ntụle Mgbochi Protease maka COVID-19 n'ime Ndị Ọrịa Kwesịrị Ekwesị) na EPIC-PEP (Ntụle nke Mgbochi Protease maka COVID- 19 na Post-Exposure Prophylaxis) ọmụmụ, nke malitere na Ọgọst na Septemba 2021 n'otu n'otu, etinyeghị na nyocha nwa oge a ma na-aga n'ihu.
Ihe gbasara nyocha nwa oge nke oge 2/3 EPIC-HR
Isi nyocha nke data nwa oge setịpụrụ enyocha data sitere na ndị okenye 1219 debanyere aha site na Septemba 29, 2021. N'oge mkpebi ịkwụsị iwere ndị ọrịa, ndebanye aha bụ na 70% nke ndị ọrịa 3,000 zubere site na saịtị nnwale ụlọ ọgwụ n'ofe North na South America, Europe, Africa, na Asia, nwere 45% nke ndị ọrịa nọ na United States.Ndị debanyere aha nwere nyocha ụlọ nyocha enwetara nyocha nke ọrịa SARS-CoV-2 n'ime ụbọchị ise nwere mgbaàmà dị nro ma dịkwa obere ma achọrọ ka ha nwee opekata mpe otu njirimara ma ọ bụ ọnọdụ ahụike metụtara ya na nnukwu ihe ize ndụ nke ibute ọrịa siri ike sitere na COVID. -19.Edebere onye ọrịa ọ bụla (1:1) iji nata PAXLOVID™ ma ọ bụ placebo ọnụ kwa awa iri na abụọ maka ụbọchị ise.
Banyere Data Nchekwa Ọmụmụ EPIC-HR Nkebi 2/3
Nyochaa nke data nchekwa gụnyere ọnụ ọgụgụ buru ibu nke ndị ọrịa 1881 na EPIC-HR, ndị data ha dị n'oge nyocha ahụ.Ihe omume ọjọọ nke ọgwụgwọ pụtara n'etiti PAXLOVID™ (19%) na placebo (21%), ọtụtụ n'ime ha dị nro na ike.N'ime ndị ọrịa a na-enyocha maka ọgwụgwọ-ihe ọjọọ mberede, obere ihe ọjọọ dị njọ (1.7% vs. 6.6%) na ịkwụsị ọgwụ ọmụmụ n'ihi ihe ọjọọ (2.1% vs. 4.1%) ka a hụrụ na ndị ọrịa nwere PAXLOVID ™ ma e jiri ya tụnyere ya. placebo, n'otu n'otu.
Banyere PAXLOVID™ (PF-07321332; ritonavir) na Mmemme Mmepe EPIC
PAXLOVID ™ bụ nyocha nke SARS-CoV-2 protease inhibitor antiviral ọgwụgwọ, ahaziri kpọmkwem ka a na-enye ya ọnụ ka enwere ike dee ya na akara mbụ nke ọrịa ma ọ bụ n'amata mbụ banyere ikpughe, nwere ike inyere ndị ọrịa aka izere ọrịa siri ike nke nwere ike iduga. ruo ụlọ ọgwụ na ọnwụ.Emebere PF-07321332 iji gbochie ọrụ SARS-CoV-2-3CL protease, enzyme nke coronavirus kwesịrị imepụtaghachi.Nchịkọta nke ritonavir dị ala na-enyere aka belata metabolism, ma ọ bụ ndakpọ, nke PF-07321332 ka ọ nọgide na-arụ ọrụ n'ime ahụ ruo ogologo oge na ntinye dị elu iji nyere aka ịlụso nje ọgụ ọgụ.
PF-07321332 na-egbochi mmegharị nje n'oge a na-akpọ proteolysis, nke na-eme tupu mmegharị RNA viral.N'ime ọmụmụ ihe izizi, PF-07321332 egosighi ihe akaebe nke mmekọrịta DNA mutagenic.
Pfizer bidoro ọmụmụ EPIC-HR na Julaị 2021 na-eso nsonaazụ nnwale ụlọ ọgwụ na agba nke 1 ma na-aga n'ihu na-enyocha nyocha nyocha na ọmụmụ EPIC ọzọ.N'August 2021, Pfizer butere usoro 2/3 EPIC-SR (Ntụle nke Inhibition Protease maka COVID-19 na ndị ọrịa nwere ihe ize ndụ), iji nyochaa ịdị mma na nchekwa na ndị ọrịa nwere nyocha achọpụtara nke ọrịa SARS-CoV-2. n'ihe egwu ọkọlọtọ (ya bụ, obere ihe ize ndụ nke ụlọ ọgwụ ma ọ bụ ọnwụ).EPIC-SR gụnyere otu ndị ọrịa ịgba ọgwụ mgbochi ọrịa nwere nnukwu ihe nrịbama mgbaàmà COVID-19 yana ndị nwere ihe ize ndụ maka ọrịa siri ike.Na Septemba, Pfizer bidoro usoro 2/3 EPIC-PEP (Ntụle nke mgbochi Protease maka COVID-19 na Prophylaxis Post-Exposure) iji nyochaa ịdị mma na nchekwa na ndị okenye kpughere SARS-CoV-2 site n'aka onye otu ezinụlọ.
Maka ozi ndị ọzọ na EPIC Phase 2/3 nnwale ụlọ ọgwụ maka PAXLOVID™, gaa na clinicaltrials.gov.
Banyere nkwenye Pfizer maka ịnweta nha nhata
Pfizer na-agba mbọ ịrụ ọrụ maka ịnweta PAXLOVID ™ ziri ezi maka mmadụ niile, na-achọ ịnapụta ọgwụgwọ mgbochi nje dị mma ma dị irè ozugbo enwere ike yana ọnụ ọnụ ọnụ.Ọ bụrụ na onye ndoro-ndoro ochichi anyị nwere ihe ịga nke ọma, n'oge ọrịa a, Pfizer ga-enye ọgwụgwọ ọgwụ mgbochi ọnụ anyị nyocha site na usoro ọnụ ahịa ọnụ ahịa dabere na ọkwa ego nke obodo ọ bụla iji kwalite nha nhata nke ịnweta n'ofe ụwa.Mba dị elu na nke etiti ga-akwụ ụgwọ karịa mba ndị na-akpata obere ego.Ụlọ ọrụ ahụ abanyela na nkwekọrịta ịzụrụ ihe n'ihu na ọtụtụ mba ma soro ọtụtụ ndị ọzọ na-akparịta ụka.Pfizer amalitelarị na ọ ga-aga n'ihu na-etinye ego ihe ruru ijeri $1 iji kwado mmepụta na nkesa ọgwụgwọ nyocha a, gụnyere ịchọpụta nhọrọ nrụpụta nkwekọrịta iji nyere aka hụ na ịnweta gafee mba ndị dị ala na nke etiti, na-echere ikike nchịkwa.
Ụlọ ọrụ ahụ na-arụ ọrụ iji hụ na ịnweta akwụkwọ akụkọ antiviral maka ndị kacha nwee mkpa gburugburu ụwa, na-echere nsonaazụ ule na-aga nke ọma na nkwenye nchịkwa.
Oge nzipu: Nov-19-2021