The FDA has yet to come to a conclusion on the approval of Lilly/Incyte’s JAK1/2 inhibitor Olumiant (baricitinib), AbbVie’s JAK 1 inhibitor Rinvoq (upadacitinib), and Pfizer’s, JAK 1 inhibitor Cibinqo (abrocitinib), the leading data and analytics company notes that competition will likely heighten once these JAK inhibitors become available.

Ramla Salad, Pharma Analyst at GlobalData, comments: “The European Medicines Agency (EMA) and Food and Drug Administration (FDA) have taken very different stances to approving these new therapies in the Janus kinase (JAK) inhibitor class. This divergence stems from results of the ORAL Surveillance (NCT02092467) trial, a post-marketing rheumatoid arthritis (RA) safety study of Xeljanz (tofacitinib), which highlighted the potential risk of cardiovascular problems, cancer, and other serious adverse events. This safety data has put a spotlight on the oral JAK inhibitor drug class, resulting in a lengthy dialogue among regulators, which has led to ongoing delays in the US and some cautious approvals in Europe.”

Salad continues: “The EMA has not seen the same delay, having approved Olumiant in December 2020 and Rinvoq in August 2021 for the treatment of moderate to severe AD. The agency is also expected to approve Cibinqo soon following a positive opinion in October from the Committee for Medicinal Products for Human Use (CHMP). The drug has already been approved by the Medicines and Healthcare products Regulatory Agency and is now available in the UK.

GlobalData anticipates the FDA will make some key decisions regarding JAK inhibitor approvals for AD during Q4 2021.