EMA Follows FDA in Reviewing Safety of JAK Inhibitors

February 16, 2022

The European Medicines Agency (EMA) safety committee has begun a safety review of Janus kinase (JAK) inhibitors made by Pfizer, AbbVie, Eli Lilly and Belgian biotech Galapagos for the treatment of inflammatory disorders.

EMA said the review was prompted by the results of a clinical trial of the JAK inhibitor Xeljanz (tofacitinib), which showed that patients taking the drug for rheumatoid arthritis and who were at risk of heart disease were more likely to experience a major cardiovascular problem and had a higher risk of developing cancer than those treated with TNF-alpha inhibitors, another treatment for rheumatoid arthritis.

In December, the FDA added its strictest warnings to the labels of JAK inhibitors made by Pfizer, AbbVie and Eli Lilly, citing risk of serious health issues and the possibility of death in patients age 50 and over.

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