Rinvoq is the first oral drug for moderate to severe Crohn’s disease — a chronic intestinal disorder — to be approved by the Food and Drug Administration.
There is no cure for Crohn’s disease, and the drug treatments currently available can only help with some level of remission and the relief of symptoms, which include abdominal pain, diarrhea, fatigue, weight loss, blood in the stool and malnutrition, according to the Mayo Clinic.
Rinvoq (generic name: upadacitinib) got the FDA nod Thursday after two clinical trials with 857 patients with Crohn’s disease.
“I started feeling better within a couple weeks,” Danielle, one of the study participants with Crohn’s disease, said in a statement. “My symptoms lessened — less cramping, firmer stools, and the bleeding stopped. When I stopped bleeding, I had more energy.”
The patients were randomly grouped to receive either 45 milligrams of Rinvoq daily or a placebo for 12 weeks.
The patients who received Rinvoq showed significantly less inflammation in their intestines than the placebo group after the three-month period.
In another study, 343 patients who used a low dose of Rinvoq as long-term maintenance therapy also had less inflammation after one year of use.
Rinvoq, manufactured by AbbVie Inc. of North Chicago, Illinois, belongs to a class of drugs known as Janus kinase inhibitors, which moderate the body’s immune response and ease inflammation.
Rinvoq has already been FDA-approved to treat six other immune-related disorders including rheumatoid arthritis, the skin condition atopic dermatitis and ulcerative colitis, a gastrointestinal disorder.
This seventh FDA approval for Rinvoq makes the drug a blockbuster success for AbbVie, which also manufactures the bestselling drug Humira (adalimumab), a type of immune-suppressant drug known as a TNF inhibitor.
As the patents for Humira are due to expire within a few years, Rinvoq is expected to step up as the company’s leading moneymaker.
But the FDA has increased scrutiny of all Janus kinase inhibitors in recent years due to reports of serious heart-related side effects and cancer risks, according to Fierce Pharma.
As a result of these safety concerns, JAK inhibitors including Rinvoq are now approved only for those patients who have tried but cannot tolerate or don’t respond well to TNF inhibitors such as Humira.
Doctors don’t yet know what causes Crohn’s disease, although it sometimes runs in families. In addition to immune suppressants, treatments for the condition can include anti-inflammatory drugs such as corticosteroids, antibiotics, nutritional therapies and, in moderate or severe cases, surgery.