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.
Key secondary endpoints were also met, including clinical response, endoscopic improvement and mucosal healing in induction at week ten and in maintenance at week 52.
In terms of safety, the most common treatment-emergent adverse events (TEAEs) in the study’s induction period for patients who received Zeposia versus placebo, respectively, were anaemia (4.2% vs 5.6%), nasopharyngitis (3.5% vs 1.4%) and headache (3.3% vs 1.9%).
In the maintenance period, the most common TEAEs were alanine aminotransferase increase (4.8% vs 0.4%), and headache (3.5% vs 0.4%). Infections were more common with Zeposia than with placebo during the maintenance phase of the trial (23% vs 11.9%), the company noted.
UC is an Inflammatory Bowel Disease which causes the immune system to begin attacking the gut, resulting in swelling and inflammation in the rectum and colon. Approximately one in every 227 people in the UK is diagnosed with UC, and half of those in England with UC have a moderate to severe form of the condition.
“We are extremely proud to be able to provide a new option in [Zeposia] which offers a different choice to healthcare professionals to better support patients with this challenging disease. This recommendation signals the start of an exciting time for our Innovative Medicines portfolio,” said Scott Cooke, general manager UK and Ireland, BMS.