United States approves first oral drug for Crohn’s disease
The U.S. Food and Drug Administration (FDA) approved this Thursday the use of Rinvoq as the first oral Crohn’s disease drug for some severe to moderate cases.
Specifically, the U.S. regulator allowed use of the drug for adults “who have had an inadequate response or intolerance to one or more blockers tumor necrosis factor (TNF) blockers,” the institution said in a statement.
The first regulatory agency to approve the use of Rinvoq to treat Crohn’s disease was the British MHRA in February. According to the FDA, the use of the drug may cause Crohn’s tract infections. upper respiratory tract, anemia, fever, acne or shingles, among other symptoms.
The regulator recommends starting with a dose of 45 milligrams (mg) every day for 12 weeks. After that, it is recommended to take a maintenance dose of 15 mg per day.
Experts detected a significant improvement in patients taking 45 mg of Rinvoq vs. those taking placebo in two trials in which 857 people participated.
The drug is manufactured by AbbVie Pharmaceuticals and is already used to treat several inflammatory diseases.
Crohn’s disease causes inflammation of the digestive tract. It usually causes diarrhea and intestinal pain, as well as weight loss.