Lilly/Incyte's JAK Inhibitor Baricitinib Poised For FDA Approval After All
It's possible that potential risk for thromboembolic events flagged in rheumatoid arthritis studies could be managed in labeling.
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During a mixed review by the US FDA's Arthritis Advisory Committee, panelists suggested that risks potentially associated with Lilly/Incyte's JAK inhibitor would be acceptable for a more limited patient population.
AbbVie's JAK1 inhibitor upadacitinib bested the company's blockbuster Humira in the largest and longest trial to date – on both efficacy and safety – perhaps alleviating concerns about cardiovascular events.
Low cardiovascular risk was shown in trials presented at the ACR/ARHP annual meeting for Pfizer's, Lilly's and AbbVie's JAK inhibitors in rheumatoid arthritis; AbbVie's Phase II risankizumab results in PsA, biosimilar doubts and more from ACR.