Humira Approved for Pediatric Ulcerative Colitis
The pediatric approval was based on data from the multicenter, randomized, double-blind phase 3 ENVISION I study.
Ulcerative Colitis
Upadacitinib Meets End Points in Ulcerative Colitis Trial
The U-ACCOMPLISH induction study evaluated the efficacy and safety of upadacitinib in 515 adults with moderate to severe ulcerative colitis.
Ozanimod Gets Priority Review for Ulcerative Colitis
The submission is supported by data from the True North trial that assessed ozanimod as an induction and maintenance therapy for adults with moderately to severely active UC who had an inadequate response to prior treatment.
De-Escalation and Discontinuation of Biologics in IBD: What to Consider
Although the definition of remission varies, the goal of IBD treatment is to achieve and sustain remission.
FDA to Review AVT02, a High Concentration Biosimilar to Adalimumab
AVT02 is a proposed biosimilar to Humira® (adalimumab) with high concentration (100mg/mL) dosage forms.
Clinically Meaningful Improvements With Ozanimod in UC Trial
The True North study included patients with moderate to severe ulcerative colitis who had an inadequate response to prior treatment.
Prevalence of Adverse Pregnancy Outcomes Assessed With Biologics for IBD
The study aimed to determine the prevalence of adverse pregnancy outcomes associated with biologic use in women with IBD.
Results Mixed for Etrolizumab in Ulcerative Colitis
Etrolizumab is an investigational humanized monoclonal anti-ß7 antibody designed to selectively inhibit α4β7 and αEβ7 integrins.
Efficacy of Cannabinoids in Treating IBD Examined
Significant improvements in both clinical symptoms (ie, abdominal pain, general well-being, nausea, diarrhea, and decreased appetite) as well as QoL scores were observed with cannabinoids.
Biosimilar Hulio Gets FDA Approval
The Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp; Mylan), a biosimilar to Humira® (adalimumab; AbbVie).
