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

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

It may also help children 6 or older with moderate to severe active Crohn’s who have failed to respond to conventional therapy, including nutrition therapy, a corticosteroid, and an immunomodulator.

“The approval of our first biosimilar by the European Commission is a major milestone not just for Amgen as a company, but for the millions of patients with chronic inflammatory diseases who need alternative treatment options,” Sean E. Harper, M.D., executive vice president of research and development at Amgen, said in a press release.

“In addition, Amgevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option. This milestone exemplifies our ongoing dedication to the development of high-quality biologic medicines.”

Patricia holds a Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She has also served as a PhD student research assistant at the Department of Microbiology & Immunology, Columbia University, New York.
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Patricia holds a Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She has also served as a PhD student research assistant at the Department of Microbiology & Immunology, Columbia University, New York.
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