BMS nabs FDA ok for once-daily ulcerative colitis pill

May 28, 2021

Bristol Myers Squibb announced that the U.S. FDA approved Zeposia for the treatment of adults with moderately to severely active ulcerative colitis, introducing a new option that has a different mechanism of action than available therapies.

The oral medication taken once daily is the first and only sphingosine 1-phosphate receptor modulator approved for patients with moderately to severely active UC.

The approval, based on data from True North, a pivotal phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo is the first approved gastrointestinal disease treatment for BMS' growing immunology franchise and marks the second indication for Zeposia. The FDA first approved the drug in 2020 for adults with relapsing forms of multiple sclerosis.

It's been a good month for BMS — last week the FDA approved Opdivo for adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer. The day prior to that approval, BMS announced data from a phase 2/3 trial of relatlimab and Opdivo together compared to Opdivo alone in patients with previously untreated melanoma, finding statistically significant and clinically meaningful progression-free survival in the combo.

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