European Union Approves Amgevita for Crohn’s Disease and Ulcerative Colitis

European Union Approves Amgevita for Crohn’s Disease and Ulcerative Colitis
The European Union has approved Amgen's Amgevita, a biosimilar to Humira (adalimumab), as a treatment for inflammatory bowel diseases (IBDs) such as Crohn's and ulcerative colitis. The European Commission decision applies to moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis in adults, and moderate-to-severe Crohn's in children at least 6 years old. Amgevita can also be used to treat several conditions besides inflammatory IBDs in adults and children, the EU added. The commission approved its use in adults with moderate-to-severe rheumatoid arthritis, psoriatic arthriti, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, moderate-to-severe hidradenitis suppurativa, and panuveitis. Doctors can now use Amgevita to treat children 4 and older with severe chronic plaque psoriasis, 6 and older with enthesitis-related arthritis, and 2 and older with polyarticular juvenile idiopathic arthritis. The U.S. Food and Drug Administration (FDA) approved Amgetiva in September 2016. It is known as adalimumab-atto in the United States. Europe's approval was based on the results of two Phase 3 clinical trials of Amgevita's use as a treatment for moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. Like Humira, Amgevita is a monoclonal antibody that targets tumor necrosis factor alpha. TNF alpa is a pro-inflammatory mediator that plays a critical role in inflammatory bowel disease. Amgevita may benefit adults with moderate to severe active ulcerative colitis who have failed to respond fully to conventional treatments, including corticosteroids, 6-mercaptopurine (6-MP) or azathioprine (AZA). I
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