FDA Approves First Oral Treatment For Moderate-to-Severe Crohn’s Disease

31 May 2023 • FDA has approved Rinvoq (upadacitinib), the first approved oral product available to treat moderately to severely active Crohn’s disease for adults who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Patients should start with 45 mg of Rinvoq once daily for 12 weeks. Following the 12-week period, the recommended maintenance dosage is 15 mg once a day. A maintenance dosage of 30 mg once daily can be considered for patients with refractory, severe, or extensive Crohn’s disease.

The efficacy and safety of Rinvoq were evaluated in two randomized induction trials of 857 patients with moderately to severely active Crohn’s disease. At week 12, a greater proportion of patients treated with 45 mg of Rinvoq, as compared to placebo, achieved clinical remission based on the Crohn’s Disease Activity Index (CDAI). Similarly, a greater proportion of patients treated with 45 mg of Rinvoq demonstrated improvement in intestinal inflammation as assessed by colonoscopy.

The most common side effects of Rinvoq as indicated for Crohn’s disease are upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache. Rinvoq is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biological therapies for Crohn’s disease, or with strong immunosuppressants such as azathioprine and cyclosporine.

Source: FDA | Read full story

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