The U.S. Food and Drug Administration has
approved Amgen’s AMJEVITA for the treatment of seven different inflammatory
diseases.
The diseases AMJEVITA have been approved to treat include
moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular
juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,
moderate-to-severe chronic plaque psoriasis, moderate-to-sever Crohn’s disease
in adults and moderate-to-severe ulcerative colitis. AMJEVITA is the first
adalimumab biosimilar of its kind that has received FDA approval to treat seven
different inflammatory diseases.
"Approval of AMJEVITA is an exciting accomplishment as
it marks a new chapter in Amgen's story of being a leader in biotechnology," Amgen Executive Vice President of Research and Development Dr. Sean Harper said. "In
addition, AMJEVITA holds the potential to offer patients with chronic
inflammatory diseases an additional treatment optionThis milestone exemplifies our ongoing dedication to the development of
high quality biologic medicines."
AMJEVITA received FDA approval due to the trial data showing
that it is a biosimilar to adalimumab. The data accumulated that determines
this was analytical, nonclinical, pharmacokinetic and clinical. Two Phase 3
trial results were included in the data package. Both trials met the primary
goals, which were to prove that AMJEVITA was comparable to adalimumab.
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