UK – Bristol Myers Squibb’s active ulcerative colitis treatment bags NICE recommendation

Bristol Myers Squibb's (BMS) Zeposia (ozanimod) has been recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of adults with moderate-to-severe active ulcerative colitis (UC), the company announced, marking NICE’s first recommendation of an oral sphingosine 1-phosphate (S1P) receptor modulator for UC treatment.

The recommendation is specifically for patients who are intolerant of, or whose condition has had an inadequate response, or loss of response to previous biologic therapy or conventional therapy.

The decision from NICE was supported by data from True North, a pivotal phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderate-to-severe UC.

The trial demonstrated statistically significant and clinically meaningful results for clinical remission with Zeposia compared to placebo at induction at week one. Moreover, in the maintenance phase of the study at week 52, Zeposia demonstrated statistical significance in clinical remission versus placebo…