AbbVie (NYSE:ABBV), a United States-based pharmaceutical company, announced on Monday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of upadacitinib (RINVOQ, 45mg [induction dose] and 15mg and 30mg [maintenance doses]) to treat adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

The company's application for the approval of upadacitinib in Crohn's disease is supported by data from two induction studies, U-EXCEED and U-EXCEL, and one maintenance study, U-ENDURE. During all three studies, the company said that a major proportion of patients treated with the product achieved the key secondary endpoint of endoscopic remission (defined as SES-CD less than or equal to four and at least a two-point reduction compared to baseline and no subscore >one).

Roopal Thakkar, MD, senior vice president, development, regulatory affairs and chief medical officer, AbbVie, said, 'The recent CHMP recommendation to approve upadacitinib for use in Crohn's disease is a momentous step, bringing us closer to offering a first-of-its-kind, once-daily oral treatment that can make a difference for people living with this disease. We remain steadfast in our commitment to researching and developing treatment options as part of a diverse portfolio of therapies for those living with inflammatory bowel diseases.'

Upadacitinib for is approved to treat Crohn's disease in Great Britain effective January 2023 and its safety and efficacy remain under assessment in the European Union.