What is Rainfoq? First oral drug for Crohn’s disease approved by the Food and Drug Administration


May 19, 2023 | 2:25 in the afternoon

Rinvoq is the first oral medication 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 currently available drug therapies can only help with some level of remission and relief of symptoms, which include abdominal pain, diarrhea, fatigue, weight loss, blood in stool, and malnutrition, according to the Mayo Clinic.

Rinvoq (generic name: upadacitinib) received FDA approval Thursday following two clinical trials with 857 patients with Crohn’s disease.

“I started to feel better within two weeks,” Danielle, one of the study participants with Crohn’s disease, said in a statement. “My symptoms eased—fewer cramps, firmer stools, and the bleeding stopped. When I stopped bleeding, I had more energy.”

Patients were randomly assigned to receive either 45 milligrams of Rinvoq daily or a placebo for 12 weeks.

Patients treated with Rinvoq showed significantly less inflammation in the intestine than the placebo group after the 3-month period.

In another study, 343 patients who used low-dose Rinvoq as long-term maintenance therapy also had less inflammation after one year of use.

Crohn’s disease can cause abdominal pain, cramps, diarrhea, fatigue, weight loss, and other symptoms.
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Rinvoq, manufactured by AbbVie Inc. In North Chicago, Illinois, it belongs to a class of drugs known as Janus kinase inhibitors, which work to dampen the body’s immune response and reduce inflammation.

Rinvoq is already approved to treat six other immune-related disorders including rheumatoid arthritis, atopic dermatitis and ulcerative colitis, a gastrointestinal disorder.

This seventh FDA approval of Rinvoq makes the drug a huge success for AbbVie, which also makes the best-selling Humira (adalimumab), a type of immunosuppressant drug known as a TNF inhibitor.

Rinvoq (generic name: upadacitinib) has been approved to treat Crohn’s disease by the Food and Drug Administration.

With Humira’s patents set to expire in a few years, Rinvoq can be expected to step up as the company’s leading earner.

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 Vers Pharma.

As a result of these safety concerns, JAK inhibitors including Rinvoq are now only approved for those patients who have tried but cannot tolerate or do not 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 immunosuppressants, treatments for the condition can include anti-inflammatory medications such as corticosteroids, antibiotics, nutritional therapies, and, in moderate or severe cases, surgery.

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