Humira will be the first self-administered biologic for the treatment of Crohn’s disease. This is an important milestone for Abbott, as Crohn’s disease will be the fourth approved indication for Humira.
“Humira will fill an important unmet need in Crohn’s, a condition where we’ve had few effective treatment options, by offering sustained remission from disease and improved quality of life,” said Jean-Frederic Colombel, professor of Gastroenterology, Hopital Huriez, France. “Humira has been shown to be effective even in patients who have failed other therapies.”
The European Commission is expected to issue a decision granting the marketing authorization for Humira as a treatment of Crohn’s disease in the European Union within the next 60 days. The positive opinion is based on results of three trials of Humira. Clinical remission was measured by a Crohn’s Disease Activity Index (CDAI) score of less than 150.