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.”
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