Rinvoq Approved for Moderately to Severely Active Ulcerative Colitis
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
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.
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
PillCam SB3 @HOME offers a telehealth option for direct visualization and monitoring of the small intestine.
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
A significantly greater proportion of patients treated with upadacitinib 15mg and 30mg achieved clinical remission at week 52 compared with those receiving placebo.
The FDA has approved Zeposia® (ozanimod) for moderately to severely active ulcerative colitis in adults.