FDA Pom Zoo Weltruza, thawj zaug ib hlis ib zaug Subcutaneous Olanzapine rau Cov Neeg Laus uas Muaj Schizophrenia
Teva Pharmaceuticals tau tshaj tawm rau lub Kaum Hli 9 tias Lub Chaw Saib Xyuas Khoom Noj thiab Tshuaj hauv Tebchaws Meskas tau pom zoo Weltruza (olanzapine) rau kev txhaj tshuaj ntev rau kev kho mob schizophrenia rau cov neeg laus. Nws yog thawj zaug thiab tsuas yog ib hlis ib zaug ntawm olanzapine txhaj tshuaj hauv qab daim tawv nqaij.
Olanzapine tau yog ib qho kev kho mob tseem ceeb rau tus mob schizophrenia tau ntau tshaj 30 xyoo, tab sis kev noj tshuaj txhua hnub tseem yog ib qho teeb meem loj rau ntau tus neeg mob. Weltruza raug muab ib hlis ib zaug los ntawm kev txhaj tshuaj subcutaneous thiab tsis tas yuav tsum tau noj tshuaj ntau npaum li cas, tsis tas yuav noj tshuaj olanzapine ntxiv thaum pib kho mob thiab tsis tas yuav saib xyuas tom qab txhaj tshuaj. Nws yuav muag hauv 318 mg, 425 mg thiab 531 mg zog, sib npaug rau cov tshuaj olanzapine noj txhua hnub ntawm 10 mg, 15 mg thiab 20 mg. Cov khoom siv SteadyTeq, ib qho copolymer sustained-release technology tsim los ntawm MedinCell.
Kev pom zoo yog nyob ntawm theem 3 SOLARIS kev sim, uas yog kev tshawb fawb thoob ntiaj teb, kev xaiv tsa, kev tsis pom kev, kev tshawb fawb tswj hwm los ntawm 675 tus neeg laus hnub nyoog 18 txog 64. Hauv theem yim lub lis piam uas tswj hwm los ntawm placebo, Weltruza tau ua rau muaj kev txhim kho zoo dua ntawm cov qhab nia tsos mob dua li placebo. Christoph Correll, tus xibfwb qhia txog kev puas siab puas ntsws ntawm Zucker School of Medicine ntawm Hofstra/Northwell, tau hais tias qhov kev xaiv tshiab no ua tiav cov ntshav kho mob yam tsis tas yuav kho nrog kev noj tshuaj, kev ntxiv tshuaj lossis kev txhaj tshuaj ntxiv thiab "tuaj yeem pab txhawb cov neeg mob, txhawb nqa lawv cov neeg koom tes saib xyuas thiab muab cov cuab yeej tshiab tseem ceeb rau cov kws kho mob." Tus thawj coj saib xyuas kev kho mob ntawm Teva, Eric Hughes, tau hais tias kev tshem tawm qhov xav tau kev saib xyuas tom qab txhua qhov kev txhaj tshuaj tshem tawm qhov teeb meem tseem ceeb rau kev kho mob ntev.
Weltruza muaj ib lub thawv ceeb toom txog kev pheej hmoo ntawm kev tuag rau cov neeg laus uas muaj kev puas siab puas ntsws ntsig txog kev puas hlwb thiab tsis tau pom zoo rau cov neeg ntawd. Teva xav tias cov khoom no yuav muaj nyob rau hauv Tebchaws Meskas hauv ob peb lub lis piam tom ntej.
[txuas:https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-Announces-U-S--Food-and-Drug-Administration-FDA-Approval-of-WELTRUZA-Olanzapine-For-Extended-Release-Injectable-Suspension-as-the-First-and-Only-Once-Monthly-Subcutaneous-Injectable-Olanzapine-for-Adults-with-Schizophrenia/default.aspx|Teva tsab ntawv xov xwm]
Qhov chaw: GSM · Tebchaws Meskas (Qhov kev tshaj tawm lus Askiv · Qhov kev tshaj tawm lus Suav qub)
Duab: 皮下注射剂（资料图）。Whispyhistory 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / A subcutaneous injection product (file photo). Photo by Whispyhistory, CC BY-SA 4.0, via Wikimedia Commons.
