AbbVie’s new Rinvoq indication receives FDA OK
AbbVie has obtained the Food and Drug Administration’s permission for Rinvoq (upadacitinib).
The medication is indicated for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
“There remains an unmet need for patients with moderately to severely active UC, who suffer from debilitating symptoms that are often unpredictable and burdensome,” Thomas Hudson, senior vice president of research and development, chief scientific officer of AbbVie, said. “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.”
[Read more: AbbVie gets FDA nod for Rinvoq]
This FDA approval is the first indication for Rinvoq in gastroenterology, the company said.
“Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult,” Maria Abreu, professor of medicine, professor of microbiology and immunology of the University of Miami Miller School of Medicine and director, Crohn’s & Colitis Center, University of Miami Health System, said. “In clinical trials, Rinvoq showed its ability to rapidly control symptoms in just eight weeks for many patients and sustained responses at one year. I believe these types of improvements can make a positive difference for my patients.”
Rinvoq already is approved to treat adults with moderate to severe rheumatoid arthritis when one or more medicines called tumor necrosis factor blockers have been used, and did not work well or could not be tolerated.
[Read more: AbbVie obtains FDA nod for new indication of Rinvoq]
It also is indicated to treat adults with active psoriatic arthritis when one or more medicines called TNF blockers have been used, and did not work well or could not be tolerated; to treat adults with moderately to severely active ulcerative colitis when one or more medicines called TNF blockers have been used, and did not work well or could not be tolerated; and to treat adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or when the use of other pills or injections is not recommended.