Itsva FDA Mvumo muKurapa kweUlcerative Colitis

A BATA FreeRelease 5 | eTurboNews | eTN
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rakanyorwa Linda Hohnholz

AbbVie nhasi yakazivisa kuti US Food and Drug Administration (FDA) yabvumidza RINVOQ® (upadacitinib) kurapwa kwevakuru vane zvine mwero kusvika kune yakanyanya kusimba ulcerative colitis (UC) vasina mhinduro yakakwana kana kusashivirira kune imwechete kana anopfuura bundu necrosis factor. (TNF) blockers. Iyi mvumo yeFDA ndiyo yekutanga chiratidzo cheRINVOQ mugastroenterology uye inotsigirwa nehunyanzvi uye data rekuchengetedza kubva kutatu Phase 3 randomized, double-blind, placebo-controlled controlled clinical studies.

"Pachine chido chisingawaniki chevarwere vane UC ine mwero kusvika kune yakasimba, vanotambura nezviratidzo zvinokanganisa izvo zvinowanzova zvisingatarisirwi uye zvinoremedza," akadaro Thomas Hudson, MD, mukuru mutevedzeri wemutungamiri wekutsvakurudza uye kubudirira, mukuru wezvesayenzi, AbbVie. "Nemvumo yeRINVOQ senzira nyowani yekurapa, AbbVie inoenderera mberi nehutungamiriri hwedu mukusimudzira tsvagiridzo inogona kubatsira kukanganisa hupenyu hwevanhu vanorarama neulcerative colitis."

Zvidzidzo zviviri zvekudzidzira (U-ACHIEVE uye U-ACCOMPLISH) zvakashandisa RINVOQ 45 mg kamwe chete zuva nezuva kwemavhiki masere, uyezve 8 mg kana 15 mg kamwe chete zuva nezuva nokuda kwechidzidzo chekuchengetedza (U-ACHIEVE kuchengetedza) kuburikidza nemavhiki makumi mashanu nemaviri. Pakati pemakiriniki ese ekuedzwa, zvakanyanya varwere vanobatwa neRINVOQ vakawana kuregererwa kwekliniki pamasvondo 30 ne52, kuguma kwekutanga kunobva pane mMS: stool frequency subscore (SFS) ≤ 8 uye kwete yakakura kudarika Baseline, rectal blood subscore (RBS) = 52 , endoscopy subscore (ES) ye ≤ 1 isina friability, ichienzaniswa ne placebo. Pamusoro pezvo, zvidzidzo zvakasangana ese ekupedzisira magumo ekupedzisira, anosanganisira endoscopic kunatsiridza uye histologic-endoscopic mucosal kunatsiridza (HEMI), pamwe necorticosteroid-yemahara yekiriniki yekuregererwa muchidzidzo chekuchengetedza. Yese yepuraimari uye yakasarudzika yechipiri magumo akawana p-tsika dze <0 maringe ne placebo.

"Ulcerative colitis varwere vanorarama nezviratidzo zvisingatarisirwi zvakadai sekuwedzera kwechigaro uye kubuda ropa, izvo zvinogona kuita kuti mabasa ezuva nezuva ave akaoma," akadaro Maria T. Abreu, MD, Purofesa weMishonga, Purofesa weMicrobiology uye Immunology, University of Miami Miller School of Medicine uye. Director, Crohn's & Colitis Center, University of Miami Health System.* “Muongororo dzekiriniki, RINVOQ yakaratidza kukwanisa kwayo kukurumidza kudzora zviratidzo mumavhiki masere chete kuvarwere vakawanda uye mhinduro inoramba iripo mugore rimwe chete. Ndinotenda kuti marudzi aya ekuvandudzwa anogona kuita mutsauko wakanaka kune varwere vangu. "

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Linda Hohnholz

Editor mukuru we eTurboNews yakavakirwa muTN HQ.

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