After multiple sclerosis also ulcerative colitis. This is the path taken by ozanimod, a drug that modulates the immune system, used to date in the treatment of some forms of neurodegenerative disease, and now approved in Europe also to treat the pathology affecting the intestine. The European Commission has in fact authorized its use also in adult patients with moderate to severe form in the event that conventional therapy or other biological molecules are not effective, or have lost it over time, or the patients are still intolerant. . Ozanimod, which therefore can only be used after evaluating other options, is the first and only oral sphingosine 1-phosphate (S1P) receptor modulator approved for ulcerative colitis.
“In Europe, more than 3 million people are affected by inflammatory bowel disease such as ulcerative colitis, which is a problematic and often disabling form,” said Luisa Avedano, CEO, 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 approval is based on the results of the Phase 3 True North study, published in September in the New England Journal of Medicine, which showed that taking ozanimod leads to improved conditions, measurable by endoscopic examinations, and healing of the mucous membranes, confirming the safety profile of the drug. “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” , says Silvio Danese, MD, Director, Gastroenterology and Endoscopy, IRCCS, San Raffaele Hospital and Vita-Salute San Raffaele University of Milan. “The 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. “.
Ulcerative colitis
Ulcerative colitis, a chronic inflammatory bowel disease (IBD), is characterized by an abnormal and prolonged immune response that results in inflammation and ulcers (sores) in the lining (inner lining) of the large intestine (colon) or rectum . Symptoms include blood in the stool, severe diarrhea, and frequent abdominal pain. Ulcerative colitis has a major impact on health-related quality of life related to physical ability, social and emotional well-being, and study / work skills. Many patients do not achieve an adequate response or do not respond at all to current therapies available. An estimated 12.6 million people worldwide suffer from chronic inflammatory bowel disease (IBD).
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