Heart disease risk continues European Medicines Agency will step up scrutiny of all JAK inhibitors

CompilationTom Lee

The entire drug class has come under increased scrutiny as more patients on JAK inhibitors experience heart disease-related risks

On Friday, the European Medicines Agency (EMA) said its Pharmacovigilance Risk Assessment Committee would review the safety risks of all JAK inhibitors

Currently, Pfizer Xeljanz is thought to be associated with an increased risk of death in patients, including infections, pulmonary blood clots and deep vein thrombosis

This observational study also showed that patients taking Oluminant had an increased risk of major cardiovascular problems and deep vein thrombosis

In addition to the European market, the frequent outbreak of JAK inhibitors has also led to increased regulatory pressure in the US market

The move comes in response to the regulatory agency's results from a trial involving about 4,400 people with rheumatoid arthritis who were at least 50 years old and had at least one cardiovascular risk factor

It is worth noting that Xeljanz has been approved for marketing in mainland China in March 2017 for the treatment of adult patients with moderately to severely active RA who have insufficient or intolerable response to MTX therapy

After years of steady growth since it was first approved in 2012, Xeljanz's current sales have plateaued, with the drug bringing in $2.

Reference article: Pfizer's and Lilly's JAK inhibitor safety concerns prompt Europe to scrutinize drug class