Dova Pharmaceuticals ya ce Hukumar Kula da Abinci da Magunguna ta Amurka (FDA) ta amince da wani reshenta na AkaRx sabon maganin Doptelet (avatrombopag) don magance ƙananan ƙwayoyin platelet (thrombocytopenia) a cikin manya masu fama da cutar hanta (CLD) waɗanda za a yi musu tiyata don ciwon daji ko hakori. Yana da kyau a faɗi cewa wannan shine sabon magani na uku da FDA ta amince a cikin mako guda kuma magani na farko da aka amince da shi a halin yanzu don wannan dalili.
Platelets su ne sel marasa launi da aka samar a cikin bargon kashi wanda ke taimakawa wajen haifar da gudan jini a cikin jini da hana zubar jini. Ciwon daji chemotherapy yawanci yana haifar da thrombocytopenia.
Doptelet (avatrombopag) shine ƙarni na biyu, mai karɓar maganin ƙwaƙwalwar ƙwaƙwalwar ƙwaƙwalwar ƙwaƙwalwa (TPO) sau ɗaya a kowace rana. Doptelet na iya kwaikwayon tasirin TPO, shine babban mai sarrafa samfuran platelet na yau da kullun. Magungunan miyagun ƙwayoyi sun sami cancantar nazarin fifiko don magance thrombocytopenia a cikin manya tare da CLD waɗanda za su yi tiyata.
An tabbatar da lafiyar Doptelet da tasirin sa a cikin gwaji biyu (ADAPT-1 da ADAPT-2). Wadannan karatuttukan sun hada da duka marasa lafiya 435 da ke fama da cutar hanta mai tsanani da kuma tsawa mai tsawa, wanda za a yi masa tiyata wanda yawanci ke bukatar karin jini. Wadannan gwaje-gwajen sun kimanta tasirin maganin ƙwaƙwalwa a matakan kashi biyu idan aka kwatanta da placebo na kwanaki 5 na magani. Sakamakon ya nuna cewa idan aka kwatanta da rukunin wuribo, mafi yawan marasa lafiya a cikin rukunin Doptelet na matakin kashi biyu sun ƙaru ƙididdigar platelet kuma ba sa buƙatar karɓar jinin platelet ko kowane magani na ceto a ranar tiyata kuma a cikin kwanaki 7 bayan jiyya . Illolin dake tattare da Doptelet sune zazzaɓi, ciwon ciki (ciki), tashin zuciya, ciwon kai, gajiya, da kumburin hannu da ƙafa (edema).
"Marasa lafiya da ke da karancin platelet da kuma cutar hanta da ke bukatar tiyata na da karin yiwuwar zub da jini," in ji Dokta Richard Pazdur, darektan Cibiyar Kwarewa a kan Lafiyar Kankara da mukaddashin darekta na Ofishin Hematology da Oncology Products a Cibiyar ta FDA don Nazarin Magunguna da Bincike. Countara yawan platelet. Wannan magani na iya ragewa ko kawar da buƙatar ƙarin jini, (ƙarin platelet) na iya ƙara haɗarin kamuwa da wasu munanan halayen.
