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Johnson & Johnson Applies for FDA Approval of Tremfya Subcutaneous Induction Regimen for Ulcerative Colitis
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Johnson & Johnson Applies for FDA Approval of Tremfya Subcutaneous Induction Regimen for Ulcerative Colitis
Nov 22, 2024 6:07 AM

08:47 AM EST, 11/22/2024 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Friday it has applied to the US Food and Drug Administration seeking approval of a subcutaneous induction regimen of Tremfya to treat adults with moderately to severely active ulcerative colitis.

The company said its supplemental biologics license application, or SBLA, is based on phase 3 study data of Tremfya subcutaneous induction therapy in adults with ulcerative colitis and follows a recent US approval of Tremfya for this indication.

Tremfya is currently administered through an intravenous induction regimen followed by a subcutaneous maintenance regimen, Johnson & Johnson ( JNJ ) said.

The company said the submission of the SBLA indicates Tremfya's potential to be the only IL-23 inhibitor that offers a choice of subcutaneous or intravenous induction in ulcerative colitis.

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