This is the first approval for the drug in gastroenterology and was based on data from three Phase III trials.
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The U.S. Food and Drug Administration approved AbbVie‘s Rinvoq (upadacitinib) for adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
Rinvoq was previously approved for adults with moderate to severe rheumatoid arthritis when one or more TNF blockers did not work well or weren’t tolerated; in active psoriatic arthritis, when TNF blockers didn’t work; and for severely active UC when one or more TNF blockers didn’t work.
This is the first approval for the drug in gastroenterology. It was based on data from three Phase III trials. Two induction studies, U-ACHIEVE and U-ACCOMPLISH, evaluated Rinvoq 45 mg once a day for eight weeks and then 15 mg or 30 mg once a day for the maintenance study, U-ACHIEVE maintenance, through 52 weeks. All trials demonstrated that more patients receiving Rinvoq hit clinical remission at weeks eight and 52, which was the primary endpoint based on the mMS: stool frequency subscore (SFS) less than or equal to 1 and not greater than Baseline, rectal bleeding subscore (RBS) = 0, endoscopy subscore (ES) of less than or equal to 1 without friability, compared to placebo.
The trials also met all ranked secondary endpoints. These included endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI). Also, the secondary endpoint of corticosteroid-free clinical remission in the maintenance trial.
“There remains an unmet need for patients with moderately to severely active UC, who suffer from debilitating symptoms that are often unpredictable and burdensome,” said Dr. Thomas Hudson, senior vice president of research and development, chief scientific officer, AbbVie. “With the approval of Rinvoq as a new treatment option, AbbVie continues our leadership in advancing research that can help impact the lives of people living with ulcerative colitis.”
On January 11, 2022, AbbVie confirmed previous revenue guidance on Rinvoq, predicting $7.5 billion in sales for the drug by 2025. The drug brought in a total of $517 million in the fourth quarter of 2021, and a total for the year of $1.651 billion. The company is expecting Rinvoq and another relatively new drug, Skyrizi, to pick up the slack as its mega-blockbuster Humira faces competition as its patent protection ends. Humira raked in $20.694 billion in adjusted net revenues for the drug last year. Still, it will start losing exclusivity in 2023, and numerous biosimilar competitors are waiting in the wings, ready to gobble up part of that market.
“Skyrizi and Rinvoq will be commercialized across all of Humira’s major indications — plus atopic dermatitis. We expect combined peak sales for Skyrizi and Rinvoq to exceed the peak revenues achieved by Humira,” AbbVie’s Chairman and CEO Rick Gonzalez said at the company’s annual report conference call.
“Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult. In clinical trials, Rinvoq showed its ability to rapidly control symptoms in just eight weeks for many patients and sustained responses at one year,” Dr. Maria T. Abreau, professor of medicine, professor of microbiology and immunology, University of Miami Miller School of Medicine and director, Crohn’s & Colitis Center, University of Miami Health System, said of today’s approval. “I believe these types of improvements can make a positive difference for my patients.”
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