FDA yemeje ibrutinib yo kuvura indwara zidakira-zakira (cGVHD) mu bana

Ku ya 24 Kanama 2022, Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA) cyemeje ibrutinib kuvura abarwayi b’abana barengeje umwaka 1 bafite indwara zidakira-zakira (cGVHD) bakira Nyuma yo gutsindwa kwa 1- cyangwa imirongo myinshi kuvura sisitemu.Icyerekezo cyemewe ni icy'abarwayi b'abana, muri rusange igipimo cya 60% mu cyumweru cya 25, kandi ibiyobyabwenge birimo capsules, ibinini ndetse no guhagarika umunwa.

Ibrutinib, inhibitor ya BTK ifatanije na Pharmacyclics / Johnson & Johnson, ni inzitizi ya kinase yabanje kwemererwa kuvura indwara ya lymphocytike idakira ndetse na lymphoma selile nizindi ndwara.

Suntech yibanda ku iterambere n’umusaruro w’abunzi ba farumasi na API bakoresheje ikoranabuhanga ryatsi.Kugeza ubu, isosiyete yacu yateje imbere ibicuruzwa bitatu byo hagati bya ibrutinib harimo C AS: 143900-44-1, C AS: 330792-70-6, C AS: 330786-24-8, byose bikaba byaragurishijwe mu bicuruzwa bya GMP .Muri byo, hagati ya C AS: 143900-44-1 ikorwa nubuhanga bwa chimique-enzymatique, bufite ibyiza byo kurengera ibidukikije bibisi, igiciro gito kandi cyiza.Murakaza neza kugisha inama no gufatanya!