Investigators assessed the impact of underlying comorbidities on the efficacy of fecal microbiota transplantation in children with recurrent Clostridioides difficile infection.
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
The PAS is supported by data from the REFLECTIONS B538-12 study, which assessed multiple switches between Abrilada and Humira, in addition to methotrexate, in adults with moderate to severe rheumatoid arthritis.
Investigators assessed whether changes in fecal calprotectin levels better predict achievement of remission than levels at diagnosis in children with ulcerative colitis.
Investigators assessed the effects of 300 mg daily thiamine on maintaining levels of fatigue in patients with IBD previously receiving high-dose thiamine.
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
LUCENT-2 is a maintenance study evaluating the efficacy and safety of mirikizumab in patients who achieved clinical response in the 12-week LUCENT-1 induction study.
Given that immunogenicity to biologics may contribute to IBD treatment failure, the study authors sought to determine the rate of ADA formation to individual biologic agents.
Researchers assessed the efficacy and safety of a novel form of bioenhanced curcumin for treatment of mild to moderately active ulcerative colitis.
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
