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Xinhua | Hana hou ʻia: 2020-11-11 09:20

FILE PHOTO: Hōʻike ʻia ka logo Eli Lilly ma kekahi o nā keʻena o ka hui ma San Diego, Kaleponi, US, Kepakemapa 17, 2020. [Photo/Agencies]
WASHINGTON - Ua hoʻopuka ʻo US Food and Drug Administration i kahi mana hoʻohana pilikia (EUA) no ka lāʻau lapaʻau ʻAmelika ʻo Eli Lilly's monoclonal antibody therapy e mālama i ka COVID-19 maʻalahi i nā maʻi maʻi makua a me nā keiki.

Ua ʻae ʻia ka lāʻau lapaʻau, bamlanivimabnā maʻi maʻi COVID-19he 12 mau makahiki a ʻoi aku paha ma ka liʻiliʻi he 40 kilokani, a he pilikia nui no ka holomua ʻana i ka COVID-19 a (a i ʻole) i ka haukapila, e like me ka ʻōlelo a ka FDA ma ka Pōʻakahi.

Hoʻopili kēia i ka poʻe he 65 mau makahiki a ʻoi paha, a i ʻole i loaʻa i kekahi mau maʻi maʻi maʻi.

ʻO nā antibodies monoclonal he mau protein i hana ʻia e ka laboratory e hoʻohālike i ka hiki o ka ʻōnaehana pale ke kaua aku i nā antigens ʻino e like me nā maʻi. ʻO Bamlanivimab kahi antibody monoclonal i kuhikuhi pono ʻia e kūʻē i ka protein spike o SARS-CoV-2, i hoʻolālā ʻia e ālai i ka hoʻopili ʻana o ka maʻi a me ke komo ʻana i loko o nā sela kanaka.

ʻOiai ke hoʻomau nei ka loiloi ʻana i ka palekana a me ka maikaʻi o kēia lāʻau hoʻokolokolo, ua hōʻike ʻia ka bamlanivimab i nā hoʻokolohua lapaʻau e hōʻemi i ka hale maʻi pili i ka COVID-19 a i ʻole ke keʻena pilikia (ER) kipa i nā poʻe maʻi i ka piʻi nui o ka maʻi i loko o 28 mau lā ma hope o ka mālama ʻana ke hoʻohālikelike ʻia. i placebo, wahi a ka FDA.

Hoʻokumu ʻia ka ʻikepili e kākoʻo ana i ka EUA no ka bamlanivimab i kahi loiloi interim mai kahi ʻāpana ʻelua i hoʻāʻo ʻia, pālua-makapō, placebo-controlled clinical trial ma 465 mau kānaka makua ʻole i hoʻokipa ʻia me nā hōʻailona COVID-19 maʻalahi.

ʻO kēia mau mea maʻi, 101 i loaʻa i ka 700-milligram dose o bamlanivimab, 107 i loaʻa i ka 2,800-milligram dose, 101 i loaʻa i ka 7,000-milligram dose a 156 i loaʻa kahi placebo i loko o ʻekolu mau lā o ka loaʻa ʻana o ka hōʻailona lapaʻau no ka SARS-CoV maikaʻi mua. 2 ho'āʻo viral.

No nā poʻe maʻi i pilikia nui no ka piʻi ʻana o ka maʻi, ua kipa ʻia nā halemai a me ke keʻena pilikia (ER) ma 3 pakeneka o nā maʻi i mālama ʻia e ka bamlanivimab ma ka awelika i hoʻohālikelike ʻia me ka 10 pakeneka o nā maʻi i mālama ʻia i placebo.

ʻO nā hopena ma ka viral load a me ka hōʻemi ʻana i nā hale maʻi a me nā kipa ER, a me ka palekana, ua like ia me nā mea maʻi e loaʻa ana i kekahi o nā dosis bamlanivimab ʻekolu, e like me ka FDA.

ʻAe ka EUA i ka bamlanivimab e puʻunaue a lawelawe ʻia ma ke ʻano he hoʻokahi maʻi intravenously e nā mea mālama ola.

"ʻO ka ʻae ʻana o ka FDA no ka bamlanivimab e hāʻawi i nā limahana mālama olakino ma ka laina mua o kēia maʻi maʻi me kahi mea hana ʻē aʻe i ka mālama ʻana i nā maʻi COVID-19," wahi a Patrizia Cavazzoni, ka luna hoʻomalu o ka FDA's Center for Drug Evaluation and Research. "E hoʻomau mākou i ka loiloi i nā ʻikepili hou e pili ana i ka palekana a me ka pono o ka bamlanivimab i ka wā e loaʻa ai."

Ma muli o ka loiloi ʻana i ka nui o nā hōʻike ʻepekema i loaʻa, ua hoʻoholo ka FDA he kūpono ke manaʻoʻiʻo e hiki i ka bamlanivimab ke hana maikaʻi i ka mālama ʻana i nā maʻi maʻi maʻi ʻole me ka COVID-19 maʻalahi. A, i ka wā i hoʻohana ʻia e mālama i ka COVID-19 no ka heluna kanaka i ʻae ʻia, ʻoi aku ka nui o nā pōmaikaʻi i ʻike ʻia a ʻoi aku ka maikaʻi o ka lāʻau lapaʻau, e like me ka FDA.

ʻO nā hopena ʻaoʻao o ka bamlanivimab e pili ana i ka anaphylaxis a me nā hopena pili i ka infusion, nausea, diarrhea, dizziness, headache, itching and vomiting, e like me ka ʻoihana.

Ua hele mai ka EUA ma mua o ʻAmelika Hui Pū ʻIa ma mua o 10 miliona mau hihia COVID-19 i ka Pōʻakahi, 10 mau lā ma hope o ka paʻi ʻana i 9 miliona. ʻO ka helu awelika o nā maʻi hou i kēlā me kēia lā ua ʻoi aku ma mua o 100,000, a ua ʻōlelo aku ka poʻe loea olakino e komo ana ka ʻāina i ka pae ʻino loa o ka maʻi maʻi.