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FDA Approves Simponi For Ulcerative Colitis

This article was originally published in The Pink Sheet Daily

Executive Summary

J&J received approval to market a second TNF inhibitor to treat the bowel disorder. The authorization comes as Simponi’s increasing sales point toward blockbuster status.

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Though the initial effects were better in the GEMINI I study in ulcerative colitis than in the GEMINI II study in Crohn’s, the effects of the selective integrin antagonist became more evident by week 28 during the maintenance phase of that trial, researchers note in the New England Journal of Medicine.

Takeda’s Vedolizumab Better At Inducing Response In Ulcerative Colitis Than Crohn’s Disease

Though the initial effects were better in the GEMINI I study in ulcerative colitis than in the GEMINI II study in Crohn’s, the effects of the selective integrin antagonist became more evident by week 28 during the maintenance phase of that trial, researchers note in the New England Journal of Medicine.

Takeda’s Vedolizumab Better At Inducing Response In Ulcerative Colitis Than Crohn’s Disease

Though the initial effects were better in the GEMINI I study in ulcerative colitis than in the GEMINI II study in Crohn’s, the effects of the selective integrin antagonist became more evident by week 28 during the maintenance phase of that trial, researchers note in the New England Journal of Medicine.

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