First pill approved for moderate-to-severe Crohn's treatment by FDA

The US Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib) as a new treatment option for patients with Crohn's disease who have not responded to TNF blockers. Rinvoq is a daily pill and the first oral treatment option for this group of patients. The medication has previously been approved for other conditions like eczema, rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. In two randomized trials in 857 patients with Crohn's disease, participants received either 45 mg of Rinvoq or a placebo daily for 12 weeks. The results showed that more patients treated with the medication achieved remission than those treated with the placebo. The FDA has also assessed Rinvoq as a maintenance treatment, and this showed that more of those on the maintenance treatment achieved remission and reduced intestinal inflammation than those on the placebo. However, side effects of the medication were upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache. The drug is not recommended for use with other Janus kinase (JAK) inhibitors, biological therapies for Crohn’s disease, or with strong immunosuppressants including azathioprine and cyclosporine. Among the risks are serious infections, death, cancer, major adverse cardiovascular events, and thrombosis. The FDA recommends that patients should take 45 mg of Rinvoq once daily for 12 weeks and then start a 15 mg maintenance dose. A higher 30 mg maintenance dose can be considered for patients with refractory, severe, or extensive Crohn’s disease. Overall, this new treatment option offers hope for those with Crohn's disease who have not responded to previous treatment options.