FDA approves Johnson & Johnson GI treatment

The FDA has approved Johnson & Johnson’s Tremfya to treat adults with moderate to severe ulcerative colitis. 

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It is the first and only approved fully human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23, which is a driver of UC, according to a Sept. 11 press release. 

Tremfya is administered as a 200 milligram induction dose intravenously at weeks zero, four and eight by a healthcare professional. 

It first received FDA approval in 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis.

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