Ua ʻae ʻo FDA i ka ibrutinib no ka mālama ʻana i ka maʻi graft-versus-host maʻi (cGVHD) i nā keiki

Ma ʻAukake 24, 2022, ua ʻae ka US Food and Drug Administration (FDA) i ka ibrutinib no ka mālama ʻana i nā maʻi pediatric i ʻoi aku ma mua o 1 makahiki me ka maʻi graft-versus-host maʻi (cGVHD) e loaʻa ana Ma hope o ka pau ʻole o ka 1- a i ʻole ka laina nui. lāʻau ʻōnaehana .ʻO ka hōʻailona i ʻae ʻia no ka poʻe maʻi pediatric, me ka helu pane holoʻokoʻa o 60% i ka pule 25, a ʻo ka hoʻokumu ʻana o ka lāʻau i loaʻa nā capsules, nā papa a me nā hoʻokuʻu waha.

ʻO Ibrutinib, he mea hoʻopaneʻe BTK i hoʻomohala pū ʻia e Pharmacyclics/Johnson & Johnson, he kinase inhibitor i ʻae mua ʻia no ka mālama ʻana i ka leukemia lymphocytic maʻi a me ka lymphoma cell a me nā maʻi ʻē aʻe.

Kūleʻa ʻo Suntech i ka hoʻomohala ʻana a me ka hana ʻana i nā kikowaena lāʻau lapaʻau a me nā API e hoʻohana ana i ka ʻenehana ʻōmaʻomaʻo.I kēia manawa, ua hoʻomohala kā mākou hui i ʻekolu huahana waena o ibrutinib me C AS: 143900-44-1, C AS: 330792-70-6, C AS: 330786-24-8, ua kūʻai ʻia nā mea āpau i nā hale hana GMP. .I waena o lākou, ʻo ka waena o C AS: 143900-44-1 ka mea i hana ʻia e ka ʻenehana-enzymatic ʻenehana, nona nā mea maikaʻi o ka pale kūlohelohe ʻōmaʻomaʻo, ke kumu kūʻai haʻahaʻa a me ke ʻano kiʻekiʻe.Welina mai e kūkākūkā a hui pū!