JAK Inhibitors Come Under EMA Scrutiny On Safety Concerns: All You Need To Know

Following the FDA's issuance of a safety warning regarding JAK inhibitors, the safety committee of the European Medicines Agency initiated a review of these treatments, which are used to treat several chronic inflammatory disorders like rheumatoid arthritis and atopic dermatitis.

• The EMA's PRAC said its review was prompted by the final results from a clinical trial of Pfizer Inc's PFE JAK inhibitor Xeljanz (tofacitinib).
• The results showed that patients taking Xeljanz 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.
• Related: FDA Hits JAK inhibitors With Heart Safety, Cancer Warnings: All You Need To Know.
• In December, Xeljanz and AbbVie Inc's ABBV Rinvoq, both JAK inhibitors, received FDA approval for new indications but on one condition: They can only be taken after a patient has failed on one or more TNF blockers.
• In addition, EMA said preliminary findings from an observational study involving another JAK inhibitor, Eli Lilly And Co's LLY Olumiant (baricitinib), also suggest an increased risk of major cardiovascular problems and VTE in patients with rheumatoid arthritis treated with Olumiant compared with those treated with TNF-alpha inhibitors.
• "PRAC will therefore review to determine whether these risks are associated with all JAK inhibitors authorized in the EU for the treatment of inflammatory disorders and whether the marketing authorizations for these medicines should be amended," the EMA added.
• Also See: FDA Gives Back To Back Approval To Pfizer's & AbbVie's JAK Inhibitors For Atopic Dermatitis.
• Price Action: PFE shares are down 1.65% at $49.94 during the premarket session on the last check Monday. LLY stock closed at $235.61 on Friday.