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Johnson & Johnson Files Application With US FDA Seeking Approval of Tremfya to Treat Crohn's Disease
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Johnson & Johnson Files Application With US FDA Seeking Approval of Tremfya to Treat Crohn's Disease
Jun 20, 2024 2:09 PM

04:55 PM EDT, 06/20/2024 (MT Newswires) -- Johnson & Johnson ( JNJ ) announced late Thursday that it filed a supplemental biologics license application with the US Food and Drug Administration seeking approval for Tremfya to treat adults with Crohn's disease.

The filing is backed by 48-week data from the phase 3 Galaxi and Graviti programs, the company said.

This is the second filing with the FDA for Tremfya in inflammatory bowel disease in 2024 after an application in March for ulcerative colitis.

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