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Ulcerative Colitis: Update Bulletin [December 2016]

Product Code:
Publication Date:
December 2016

Gain new KOL insights on the latest events that have the potential to impact the treatment landscape of ulcerative colitis (UC). Topics covered include expert opinions on: Galapagos obtaining US and EU regulatory approval to commence Phase III trials for its JAK1 inhibitor, filgotinib, in patients with UC and Crohn’s disease; the US Food & Drug Administration (FDA) approving Amgen’s Amjevita (adalimumab-atto), a biosimilar of Humira (adalimumab; AbbVie), for multiple inflammatory diseases, including Crohn's disease and UC; and TopiVert announcing that the first patients have been dosed in its Phase IIa proof-of-concept study to evaluate the safety, tolerability and efficacy of a rectal formulation of TOP1288, a narrow spectrum kinase inhibitor, in symptomatic UC patients with moderate-to-severe disease activity.

Business Questions:

  • Do KOLs believe that a highly specific JAK1 inhibitor, like filgotinib, will have a future role in the treatment of UC and Crohn’s disease?
  • Do experts have any major safety concerns about filgotinib, and how do these concerns rank against those raised for other JAK inhibitors?
  • How do the KOLs view the design and primary outcome measures of Galapagos’ DIVERSITY and SELECTION studies, and would they do anything differently?
  • Do KOLs have any concerns about the approval of Amgen’s Amjevita, a Humira biosimilar, particularly in relation to both IBD indications being awarded by extrapolation?
  • What are KOL opinions on the novel mechanism of action and rectal formulation of TopiVert’s TOP1288, which is now in Phase IIb testing?
  • Do KOLs see TOP1288 having a role in the treatment of IBD in the future, and which current treatments do KOLs believe it will compete with?


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