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AbbVie Receives Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

AbbVie Receives Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
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United statesKori wallaceVan asscheEdouard louisGastroenterol hepatolExchange commissionUniversity hospitalNational institute of diabetesBoehringer ingelheimAssociation between disease activityEuropean medicines agencyEuropean commissionCommittee for medicinal products human useDrug administrationEuropean unionCrohn colitis foundation of america

AbbVie Submits Regulatory Applications to FDA and EMA for Risankizumab (SKYRIZI®) in Ulcerative Colitis

Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission and key secondary endpoints as an induction and maintenance.

Roopal thakkarCrohn colitis foundation of americaEuropean medicines agencyExchange commissionAbbvie ltdDrug administrationBoehringer ingelheimAbbvie incAdapted mayo scoreMayo scoreAdapted mayoImportant safety informationMedication guideConsumer brief summaryPregnancy registryFull prescribing information

AbbVie (ABBV) Reports Risankizumab Met Primary and Key Secondary Endpoints in Phase 3 Maintenance Study

AbbVie (ABBV) Reports Risankizumab Met Primary and Key Secondary Endpoints in Phase 3 Maintenance Study
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Boehringer ingelheimEfficacy resultsEndoscopic mucosal improvementAdapted mayo

Risankizumab (SKYRIZI®) Met Primary and Key Secondary Endpoints in 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients

Risankizumab (SKYRIZI®) Met Primary and Key Secondary Endpoints in 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients
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Ann gastroenterolStefan schreiberRoopal thakkarAbbvie incExchange commissionCrohn colitis foundation of americaBoehringer ingelheimUniversity hospital schleswig holsteinDrug administrationEuropean medicines agencyEndoscopic mucosal improvementAdapted mayoImportant safety informationMedication guideConsumer brief summaryPregnancy registry

Rinvoq Found Safe, Effective for Ulcerative Colitis in Ongoing Phase 3 Trial

Rinvoq (upadacitinib), an anti-inflammatory, was found to be safe and effective in treating moderate-to-severe ulcerative colitis in adults.

Silvio daneseMichael severinoAdapted mayo