FDA Pom Zoo Hepcludex: Kev Kho Mob Thawj Zaug Rau Kev Mob Hepatitis Delta Virus Ntev
Lub Koom Haum Saib Xyuas Khoom Noj thiab Tshuaj (FDA) ntawm Tebchaws Meskas tau pom zoo Gilead Sciences' Hepcludex rau kev kho mob tus kab mob hepatitis delta virus (HDV), thawj txoj kev kho mob tau pom zoo rau tus kab mob.
HDV tsuas yog tuaj yeem rov ua dua rau cov neeg uas muaj tus kab mob siab B thiab suav tias yog cov kab mob siab hnyav tshaj plaws. Hauv kev sim MYR301 txhawb nqa kev pom zoo, qhov kev teb ua ke ntawm lub lim tiam 48 yog 48% nrog Hepcludex piv rau 2% nrog kev kho mob qeeb. HDV RNA uas tsis pom tau tau ua tiav los ntawm 20% ntawm cov neeg mob kho mob ntawm lub lim tiam 48 piv rau 0%, nce mus txog 36% ntawm lub lim tiam 96 thiab 50% ntawm lub lim tiam 144.
Hepcludex muab ib zaug ib hnub ntawm 8.5 mg. Cov tshuaj muaj ib lub thawv ceeb toom tias kev tsis noj tshuaj yuav ua rau muaj kev mob hnyav ntawm HDV thiab kab mob siab B. Cov kev mob tshwm sim suav nrog kev ua xua xws li anaphylaxis, kev ua xua ntawm qhov txhaj tshuaj, mob taub hau, mob plab, qaug zog thiab khaus.
FDA tau tso cai rau cov tshuaj Breakthrough Therapy thiab Orphan Drug ua ntej lawm, thiab kev pom zoo tau tso cai raws li Priority Review los ntawm Accelerated Approval pathway.
(Tau los ntawm: Daim ntawv tshaj tawm kev pom zoo ntawm U.S. Food and Drug Administration)
Qhov chaw: GSM · Tebchaws Meskas (Qhov kev tshaj tawm lus Askiv · Qhov kev tshaj tawm lus Suav qub)
Duab: 肝脏三维医学示意图。（Wikimedia Commons，CC BY-SA 4.0，Scientific Animations作）A 3D medical illustration of the human liver. (Wikimedia Commons, CC BY-SA 4.0, by Scientific Animations)
