BioPharma, Pharma

AbbVie’s Rinvoq Lands FDA Approval as First Oral Drug for Crohn’s Disease

FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.

The inflammatory bowel disorder Crohn’s disease can be treated by several different biologic drugs administered as injections or infusions. The FDA just approved the first daily pill for the chronic condition.

Rinvoq, a blockbuster AbbVie drug already approved for multiple autoimmune and inflammatory disorders, is now approved as a treatment for moderately to severely active Crohn’s disease. The decision announced Thursday specifically covers the treatment of adults whose disease has not been adequately managed by tumor necrosis factors inhibitors, a class of biologic drugs currently used to treat the disorder.

The AbbVie drug belongs to a class of therapies that block Janus kinases (JAKs), a family of enzymes that play key roles in signaling pathways associated with inflammation. Rinvoq won its first FDA approval in 2019 for the treatment of moderate-to-severe rheumatoid arthritis. Crohn’s disease is a chronic inflammatory bowel condition that causes inflammation in the digestive tract. While the location and severity of this intestinal inflammation varies, common symptoms include diarrhea, cramps and stomach pain, and weight loss.

FDA approval of Rinvoq for Crohn’s disease is based on the results of two clinical trials that enrolled 857 patients total. Those participants were randomly assigned at a 2:1 ratio to receive the AbbVie drug or a placebo once a day for 12 weeks. The main goal was to show clinical remission, which was measured according to a scale used to assess the severity of Crohn’s disease symptoms.

Results showed that at week 12, a greater proportion of those who received Rinvoq achieved clinical remission compared to those in the placebo group. Also, a greater proportion of patients who received the AbbVie drug showed improvement in intestinal inflammation as assessed by a colonoscopy.

In yet another Phase 3 study, Rinvoq was assessed as a maintenance treatment for Crohn’s disease. Study participants were again randomly assigned to receive one of two doses of Rinvoq or a placebo for 52 weeks. At week 52, the results showed a greater proportion of those who received the AbbVie drug achieved clinical remission compared to who received a placebo.

The most common side effects reported from the Crohn’s disease studies included upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache. The drug’s label still carries a black box warning that cautions physicians and patients about the risk that those who use JAK inhibitors have higher rates of cardiovascular complications and cancer. That warning also covers other JAK-blocking drugs following greater FDA scrutiny on the potentially fatal adverse effects associated with the drug class.

For those taking Rinvoq for Crohn’s disease, the FDA said the drug is not recommended for use in combination with other JAK inhibitors, nor should it be used alongside strong immune system suppressing drugs such as azathioprine and cyclosporine.

FDA approval of Rinvoq for Crohn’s disease marks the drug’s second intestinal indication. Last year, the agency approved the drug for treating moderately to severely active ulcerative colitis. Crohn’s disease is Rinvoq’s seventh indication. Its approved uses include treatment of atopic dermatitis, ankylosing spondylitis, and axial sponyloarthritis. In 2022, AbbVie reported more than $2.5 billion in Rinvoq sales.

“AbbVie recognizes the need for more treatment options for Crohn’s disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage,” Thomas Hudson, senior vice president of research and development and chief scientific officer at AbbVie, said in a prepared statement. “We’re pleased that Rinvoq may provide this relief and is now available to treat Crohn’s disease.”

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