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Rheumatoid Arthritis: Update Bulletin #1 [June 2018]

Product Code:
Publication Date:
June 2018

This edition presents key opinion leader (KOL) views on recent developments in the rheumatoid arthritis (RA) market. Topics covered include; Lilly and Incyte’s announcement that an FDA advisory committee voted in favour of the 2 mg dose of Olumiant (baricitinib), while voting by the same margin against the approval of the 4 mg dose; AbbVie announcing that its Phase III SELECT-COMPARE trial, evaluating upadacitinib in RA, met its primary endpoints; and UCB announcing that the FDA approved a label update to Cimzia (certolizumab pegol) which includes pharmacokinetic data showing negligible to low transfer of the drug through placenta and minimal transfer to breast milk from mother to infant.

Business Questions:

• What are KOLs’ reactions to the FDA advisory committee’s stance on Olumiant 2mg dose versus the 4 mg dose?
• How do experts view the two doses of Olumiant?
• According to KOLs, how is this FDA decision likely to impact Olumiant’s chances of success?
• What are KOLs’ views on the Phase III SELECT-COMPARE trial of upadacitinib?
• Will upadacitinib be able to compete with the currently marketed JAK inhibitors?
• Do KOLs think the updated label for Cimzia will affect prescribing volume? Why?/Why not?


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