Humira, one of the world's best selling drugs, has been approved by the European Commission for the treatment of ulcerative colitis (UC) in adult patients.
The latest approval marks the seventh indication for the drug in the European Union since the product's first approval in 2003.
The drug, developed by Abbott Laboratories, is also indicated for the treatment of severely active rheumatoid arthritis, active polyarticular juvenile idiopathic arthritis, moderate to severe chronic plaque psoriasis, and severely active Crohn's disease.
Humira (adalimumab) has now become the first and only self-injectable biologic therapy for the treatment of moderately to severely active ulcerative colitis, a chronic inflammatory bowel disease that causes ulcers in the colon.
UC San Diego Health System and lead investigator William Sandborn said, "This is a difficult-to-treat chronic disease with limited treatment options.
"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," said Sandborn.
European Federation of Crohn's & Ulcerative Colitis Associations chairman Marco Greco said the approval represents an important new therapeutic option for people with UC.
"Having one more option to treat this disease provides new hope that some patients will be able to achieve remission of their disease."
The approval was based on two Phase III clinical trials involving more than 800 patients in 21 countries across the globe.
Sales of Humira are forecast by analysts to be around $9 billion this year, reports Reuters.