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Expert Panel: Initial Views on FDA Warnings for JAK Inhibitors

Sep 02, 2021 4:21 pm

Dr. Jack Cush is joined by Drs. Roy Fleischmann (Dallas), Allan Gibofsky (NYC), and Artie Kavanaugh (San Diego) to discuss the 9/2/21 FDA Drug Safety Communication regarding the cardiovascular and cancer risks arising from the Pfizer 1133 (ORAL Surveillance) tofacitinib study, but also applied to baricitinib and upadacitinib.

Author Disclosures 

  • Jack Cush, MD: Advisor/Consultant: Abbvie, Novartis, Amgen, BMS. (Investigator on Pfizer 1133 trial)
  • Roy Fleischmann, MD: Consultant: AbbVie, Amgen, BMS, Galvani, Gilead, GSK, Jansen, Eli Lilly,  Novartis, Pfizer, Sanofi Aventis, UCB    Clinical Trial Grants: AbbVie, Amgen, BMS, Flexion, Galapagos, Genentech, Gilead, GSK, Horizon, Eli Lilly, Novartis, Noven, Pfizer, Regeneron, Roche, Samumed, Sanofi Aventis, Selecta, Teva, UCB, Viela, VORSO
  • Artie Kavanaugh, MD: Consultancy – AbbVie, Amgen, Celgene, Chugai, Corrona, Covagen, Galapagos, Genentech/Roche, Janssen, Merck, Novartis, Pfizer, Sanofi, UCB; Research funding – AbbVie, Amgen, Astellas, Biogen-Idec, BMS, Celgene, Genentech/Roche, HGS, Janssen, Kirin, Pfizer, Regeneron, Sanofi, UCB
  • Allan Gibofsky, MD: Speaker-AbbVie, Lilly, Pfizer   Consultant-AbbVie, Pfizer   Shareholder-Abbvie, Pfizer; Special Employee – FDA
The author has received compensation as an advisor or consultant on this subject

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