www.fdanews.com/articles/211954-fda-and-nice-approve-abbvies-rinvoq-for-moderate-to-severe-crohns

FDA and NICE Approve AbbVie’s Rinvoq for Moderate to Severe Crohn’s

May 22, 2023

The FDA has approved — and the UK’s National Institute for Health and Care Excellence (NICE) has issued positive guidance recommending — Rinvoq (upadacitini), manufactured by AbbVie, as an option for treating moderate to severe Crohn’s disease.

Crohn’s disease is a chronic, progressive digestive condition that leads to inflammation of the digestive system and results in over 20 percent of people with the condition undergoing surgery within five years of diagnosis.

In two studies, the company said that 36 percent and 46 percent of patients treated with Rinvoq 45 mg achieved clinical remission at 12 weeks, respectively, compared to 18 percent and 23 percent of patients receiving placebo. In the maintenance trial, 42 percent and 55 percent of patients treated with Rinvoq 15 mg and 30 mg achieved clinical remission at 52 weeks, respectively, compared to 14 percent of patients receiving placebo.

The drug is already approved to treat six other rheumatologic, gastrointestinal and dermatologic conditions.