The Committee for Medicinal Products for Human Use (Chmp) of the European Medicines Agency (Ema) has issued its positive opinion for upadacitinib (Rinvoq *, 45 mg induction dose and 15 and 30 mg maintenance doses) for the treatment of moderate to severe active ulcerative colitis in adult patients who have responded inadequately, have not responded or are intolerant to other conventional therapies or biologics. AbbVie makes it known.
Ulcerative colitis – the company recalls in a statement – is a chronic inflammatory disease of the large intestine that primarily affects the rectum and lower colon, but which can extend and also involve the entire colon. The impact of ulcerative colitis on patients’ quality of life is significant, mainly due to symptoms such as intestinal urgency, abdominal pain, rectal bleeding and intestinal incontinence but also due to the disability it can cause.
“As a leading company in the research and development of innovative therapeutic options for people with inflammatory bowel diseases, we are committed to discovering new solutions that go beyond symptom management to obtain documentable results also from an endoscopic and histological point of view”, he declares Annalisa Iezzi, Medical Director, AbbVie Italy. “We are pleased with the positive opinion of the CHMP for upadacitinib in ulcerative colitis, a significant step forward in helping patients with unmet needs.”
The positive opinion of the CHMP is supported by data from two clinical induction studies, ‘U-Achieve induction’ and ‘U-Accomplish’, and a maintenance study, ‘U-Achieve maintenance’. “Patients with ulcerative colitis often face numerous complications and risk relapse. Achieving crucial endpoints, such as clinical remission and mucosal healing can make a significant difference in symptom management and health-related quality of life.” comments Silvio Danese, director of Gastroenterology and Endoscopy at the San Raffaele hospital and professor of Gastroenterology at the Vita-Salute San Raffaele University in Milan. “Upadacitinib could be a promising therapeutic option for adult patients who, despite treatment with conventional therapies or biological, they continue to have moderately to severely active disease ”.
Discovered and developed by AbbVie, upadacitinib is a selective and reversible inhibitor of Jak currently being studied in a number of immune-mediated inflammatory diseases. In human cell samples, upadacitinib preferentially inhibits Jak1 or Ja1 / 3 signaling with functional selectivity on cytokine receptors that signal via Jak 2 pairs. Phase III studies with upadacitinib are ongoing – concludes the note – in the following diseases: arthritis rheumatoid, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arthritis and Takayasu’s arteritis. The use of upadacitinib in ulcerative colitis has not yet been approved and its safety and efficacy have not been evaluated by regulatory authorities outside the United States and Puerto Rico.
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