AbbVie’s Rinvoq (upadacitinib) has been approved by the US Food and Drug Administration (FDA) as a treatment option for adults with moderately to severely active Crohn’s disease, the company announced.
The authorisation, which marks the seventh FDA approval for the oral JAK inhibitor, specifically applies to patients who have had an inadequate response, lost response or were intolerant to conventional therapy or a biological agent.
Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. The condition is one of the two main types of inflammatory bowel disease, which affects nearly one in every 100 people in the US.
Despite the availability of a range of treatments for Crohn’s disease, not every patient achieves long-lasting remission, and the progressive damage from disease flare-ups can result in some patients requiring surgery.
Thomas Hudson, senior vice president of research and development, chief scientific officer at AbbVie, said the company “recognises the need for more treatment options for Crohn’s disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage”.
“We’re pleased that Rinvoq may provide this relief and is now available to treat Crohn’s disease,” Hudson added.
The FDA’s decision was supported by data from three phase 3 trials, including two induction studies – U-EXCEED and U-EXCEL – and the U-ENDURE maintenance study.
Across all three studies, significantly more Rinvoq-treated patients achieved the co-primary endpoints of clinical remission and endoscopic response, with clinical remission measured by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP).
Additionally, a higher proportion of patients receiving a once daily 45mg dose of Rinvoq at week 12 in the induction studies or 15mg and 30mg once daily at 52 weeks in the maintenance study achieved the secondary endpoint of corticosteroid-free clinical remission per SF/AP compared to placebo.
“Symptoms of moderately to severely active Crohn’s disease can be disruptive and uncomfortable for patients, so relief as early as possible is key,” said U-EXCEL study investigator, Edward Loftus. “Given the progressive nature of the disease, endoscopic response is just as important.”
“Based on the clinical trial results, treatment with Rinvoq shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation,” Loftus said.