The European Commission has approved HUMIRA® (adalimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy.
With this approval, HUMIRA becomes the first and only self-injectable biologic therapy for the treatment of moderately to severely active ulcerative colitis in adults. The approval also marks the seventh indication for HUMIRA in the European Union since the product’s first approval in 2003.
UC is a chronic inflammatory bowel disease that causes ulcers in the colon and may lead to life-threatening complications.
It is estimated that UC affects up to 1.2 million people in the European Union. It is also estimated that up to one third will undergo surgical removal of the colon during their lifetimes – leaving patients with a permanent colostomy or ileal pouch.
“This is a difficult-to-treat chronic disease with limited treatment options,” said William J. Sandborn, M.D., chief, Division of Gastroenterology at UC San Diego Health System and lead investigator.
“A new therapeutic option used for the induction and maintenance of remission, with the convenience of self-administering at home is welcomed among this unique patient population.”
“This approval represents an important new therapeutic option for people with UC,” said Marco Greco, chairman of the European Federation of Crohn’s & Ulcerative Colitis Associations.
“Having one more option to treat this disease provides new hope that some patients will be able to achieve remission of their disease.”
HUMIRA is also indicated for the treatment of several other inflammatory diseases, including moderately to severely active rheumatoid arthritis, active polyarticular juvenile idiopathic arthritis, moderate to severe chronic plaque psoriasis, and severely active Crohn’s disease, when conventional treatment has failed.
The new indication for moderately to severely active ulcerative colitis further supports the use of HUMIRA for the treatment of inflammatory bowel diseases.
The approval was based on two Phase III clinical trials involving more than 800 patients in 21 countries across the globe.