(ANSA) – ROME, 01 DEC – The European Commission has authorized the indication of a drug, ozanimod, to treat the most critical patients of ulcerative colitis (in moderate or severe phase), who have had an inadequate response to therapies conventional.
The medicine is the first oral sphingosine 1-phosphate receptor modulator approved for this disease, and represents a new opportunity to treat it.
“With the approval of ozanimod for ulcerative colitis by the European Commission, patients and doctors now have an oral treatment option to be taken once daily to help address this disabling disease, with an efficacy and efficacy profile. demonstrated safety and with a different mechanism of action from other available therapies, “said Jonathan Sadeh, senior vice president of Immunology and Fibrosis Development, of Bristol Myers Squibb, the company that makes the drug.
Approval is based on data from True North, a Phase 3 study. Decreased rectal bleeding and bowel frequency were seen as early as the second week in patients treated with ozanimod.
“In Europe, more than 3 million people are affected by an inflammatory bowel disease such as ulcerative colitis, which is a problematic and often disabling form,” said Luisa Avedano, CEO of the European Federation of Crohn’s & Ulcerative Colitis Associations. “I am satisfied – she adds – because we have a new oral therapeutic option available for patients and their caregivers in managing the symptoms of a disease that can have such a heavy impact on quality of life”. (HANDLE).
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Source From: Ansa
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