European Commission green light for ozanimod in the treatment of adults with moderate to severe active ulcerative colitis, who have had an inadequate response, a loss of response, or been intolerant to conventional therapy or a biological agent. This was announced by the American Bristol Myers Squibb (Bms), explaining that the drug, to be taken by mouth once a day, is “the first and only oral sphingosine 1-phosphate (S1P) receptor modulator approved for ulcerative colitis, and represents a new opportunity to treat this chronic immune-mediated disease. “
“With today’s approval of ozanimod for ulcerative colitis by the European Commission, patients and doctors now have an oral treatment option available to take once a day to help deal with this crippling disease, with a demonstrated efficacy and safety profile and with a mechanism of action different from the other available therapies – he declares Jonathan Sadeh, Senior Vice President Immunology and Fibrosis Development, BMS – We are proud of our heritage in transformative sciences and innovative drugs that has brought us this far, and look forward to providing eligible patients in Europe with a new therapy that offers significant symptom relief and long-lasting clinical remission. “
“In Europe, more than 3 million people are affected by an inflammatory bowel disease such as ulcerative colitis, which represents a problematic and often disabling form – he says Luisa Avedano, CEO of European Federation of Crohn’s & Ulcerative Colitis Associations – I am pleased that we have a new oral treatment option available for patients and their caregivers in managing the symptoms of a disease that can have such a severe impact on quality of life. “
The OK EU – reports Bms in a note – is based on data from the phase 3 True North study, which evaluated ozanimod versus placebo as induction and maintenance therapy in adults with moderate to severe active ulcerative colitis.
During the induction – we read – at week 10 the study met the primary endpoint of clinical remission (18% ozanimod versus 6% placebo), in addition to the secondary endpoints including clinical response (48% versus 26%), the endoscopic improvement (27% versus 12%) and endoscopic-histological improvement of the mucosa (13% versus 4%). During maintenance at week 52, the study met the primary clinical remission endpoint (37% ozanimod versus 19% placebo) and key secondary endpoints including clinical response (60% versus 41%), endoscopic improvement (46% versus 26%), corticosteroid-free clinical remission (32% versus 17%) and endoscopic-histological improvement of the mucosa (30% versus 14%). Decreased rectal bleeding and bowel frequency were seen as early as week 2 in patients treated with ozanimod.. The overall safety profile was consistent with that known for ozanimod and for patients with moderate to severe ulcerative colitis.
“The results of the True North study show that ozanimod has confirmed significant and lasting efficacy in patients with moderate to severe active ulcerative colitis, for multiple key endpoints such as clinical improvement, endoscopic and mucosal healing and clinical remission – comments Silvio Danese, Director of Gastroenterology and Endoscopy, Irccs San Raffaele hospital and Vita-Salute San Raffaele University of Milan – Results related to endoscopic improvement and histological remission are particularly important because they are very difficult to achieve and indicate that ozanimod has the potential to become an effective and safe therapeutic option for physicians treating adult patients with this chronic and severe disease. “
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