Humira Approved for Pediatric Ulcerative Colitis
The pediatric approval was based on data from the multicenter, randomized, double-blind phase 3 ENVISION I study.
The pediatric approval was based on data from the multicenter, randomized, double-blind phase 3 ENVISION I study.
The U-ACCOMPLISH induction study evaluated the efficacy and safety of upadacitinib in 515 adults with moderate to severe 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.
Although the definition of remission varies, the goal of IBD treatment is to achieve and sustain remission.
AVT02 is a proposed biosimilar to Humira® (adalimumab) with high concentration (100mg/mL) dosage forms.
The True North study included patients with moderate to severe ulcerative colitis who had an inadequate response to prior treatment.
The study aimed to determine the prevalence of adverse pregnancy outcomes associated with biologic use in women with IBD.
Etrolizumab is an investigational humanized monoclonal anti-ß7 antibody designed to selectively inhibit α4β7 and αEβ7 integrins.
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.
The Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp; Mylan), a biosimilar to Humira® (adalimumab; AbbVie).