AbbVie a yau ta sanar da cewa Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince da RINVOQ® (upadacitinib) don kula da manya masu matsakaicin matsakaicin matsakaicin aiki (UC) waɗanda ba su da isasshen amsa ko rashin haƙuri ga ƙwayar cutar necrosis ɗaya ko fiye. (TNF) blockers. Wannan amincewar FDA ita ce farkon nuni ga RINVOQ a cikin ilimin gastroenterology kuma ana goyan bayan inganci da bayanan aminci daga 3 Phase XNUMX bazuwar, makafi biyu, nazarin asibiti mai sarrafa wuribo.
"Akwai sauran buƙatun da ba a biya ba ga marasa lafiya tare da matsakaici zuwa UC mai tsanani, waɗanda ke fama da cututtuka masu lalacewa waɗanda galibi ba su da tabbas kuma suna da nauyi," in ji Thomas Hudson, MD, babban mataimakin shugaban bincike da ci gaba, babban jami'in kimiyya, AbbVie. "Tare da amincewar RINVOQ a matsayin sabon zaɓi na jiyya, AbbVie ya ci gaba da jagorancinmu wajen inganta bincike wanda zai iya taimakawa wajen tasiri rayuwar mutanen da ke zaune tare da ulcerative colitis."
Nazarin ƙaddamarwa guda biyu (U-ACHIEVE da U-ACCOMPLISH) sun yi amfani da RINVOQ 45 MG sau ɗaya kowace rana don makonni 8, sannan 15 MG ko 30 MG sau ɗaya kowace rana don nazarin kulawa (U-ACHIEVE kiyayewa) ta hanyar 52 makonni. A cikin duk gwaje-gwaje na asibiti, yawancin marasa lafiya da aka bi da su tare da RINVOQ sun sami gafarar asibiti a makonni 8 da 52, farkon ƙarshen ƙarshen mMS: stool mita subscore (SFS) ≤ 1 kuma ba mafi girma fiye da Baseline, rectal blood subscore (RBS) = 0 , endoscopy subscore (ES) na ≤ 1 ba tare da friability ba, idan aka kwatanta da placebo. Bugu da ƙari, nazarin ya sadu da duk matakan ƙarshen matsayi na biyu, ciki har da haɓakar endoscopic da haɓakar mucosal na histologic-endoscopic mucosal (HEMI), da kuma maganin asibiti na corticosteroid kyauta a cikin binciken kulawa. Duk matakan ƙarshe na farko da na biyu sun sami p-darajar <0.001 tare da placebo.
"Masu fama da ciwon huhu suna rayuwa tare da alamun da ba a iya ganewa irin su ƙara yawan stool da zubar da jini, wanda zai iya sa ayyukan yau da kullum da wahala," in ji Maria T. Abreu, MD, Farfesa na Medicine, Farfesa na Microbiology da Immunology, Jami'ar Miami Miller School of Medicine da kuma Darakta, Cibiyar Crohn's & Colitis, Jami'ar Miami Health System.* "A cikin gwaje-gwaje na asibiti, RINVOQ ya nuna ikonsa na sarrafa alamun gaggawa a cikin makonni takwas kawai ga marasa lafiya da yawa da kuma ci gaba da amsawa a cikin shekara guda. Na yi imanin waɗannan nau'ikan haɓakawa na iya yin tasiri mai kyau ga marasa lafiya na. "
ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:
- Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
- “With the approval of RINVOQ as a new treatment option, AbbVie continues our leadership in advancing research that can help impact the lives of people living with ulcerative colitis.
- Across all clinical trials, significantly more patients treated with RINVOQ achieved clinical remission at weeks 8 and 52, the primary endpoint based on the mMS.
